Quality Management System (QMS) ISO 13485 Consultation | Medical Device

 The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS.  

ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment.

ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

What are the benefits of being certified to ISO 13485?

Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities.

ISO 13485 is the quality management system standard accepted as the basis for CE marking medical devices under European Directives.

Operon Strategist offers a complete range of testing, certification and auditing services to manufacturers of medical devices, helping them to manage risks. We are leading medical device Consultant service provider for Medical Device manufacturers dealing with disposable implant & syringe, surgical Instrument, Orthopaedic Implants etc. If required any assistance contact us on;  Website: https://lnkd.in/fgapCjv

 

510k Premarket Notification | Ultrasonic Diathermy Devices

Guidance for Industry, Food and Drug Administration Staff. Document issued on April 16, 2018.

Among other requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations, ultrasonic diathermy devices, also known as ultrasonic therapy or physiotherapy products, must comply with 21 CFR Part 1010 and 1050.10. This guidance document describes FDA’s recommendations for the performance standard requirements in 21 CFR 1050.10 particular to ultrasonic diathermy devices when a manufacturer has otherwise complied with certain International Electrotechnical Commission (IEC) standards.

Scope Of Ultrasonic Diathermy Products

The scope of this document is limited to ultrasonic diathermy products regulated under 21 CFR 890.5300(a), product codes IMI and PFW, and are class II devices. This guidance is applicable to ultrasonic diathermy (physiotherapy) devices for use in applying therapeutic deep heat for selected medical conditions such as relief of pain, muscle spasms, and joint contractures. This guidance only relates to equipment employing ultrasonic energy at a frequency beyond 20 kilohertz using a single plane circular transducer per treatment head producing non-convergent beams perpendicular to the face of the treatment head (i.e., collimated or divergent).

Other medical devices that include the use of ultrasound are regulated outside of 21 CFR 890.5300(a) and are excluded from the scope of this guidance. Excluded medical devices include, but are not limited to:

• Devices in which ultrasound waves are intended to destroy conglomerates (for example stones in the kidneys or the bladder) or tissue of any type;

• Devices in which a tool is driven by ultrasound (for example surgical scalpels, phacoemulsifiers, dental scalers or intracorporeal lithotripters);

• Devices in which ultrasound waves are intended to sensitize a tissue to further therapies (for example radiation or chemotherapy);

• Devices in which ultrasound waves are intended to treat cancerous (i.e., malignant) or pre-cancerous tissue, or benign masses, such as High Intensity Focused Ultrasound (HIFU) or High-Intensity Therapeutic Ultrasound (HITU); and

• Devices in which ultrasound is intended for aesthetic purposes.

 

The channel to EU MDR compliance

This blog is around a few key regions headed for MDR consistency. We have a few points that feature where organizations of various sizes and types fall with regards to the issues itemized in this paper by evaluating the difficulties they face. What’s more, will likewise give knowledge into how these progressions are probably going to happen over the long haul.

The main basic understanding the law, the difficulties, with under two years until the check runs out, it might amaze discover that 78% of medicinal device organizations don’t yet trust that they have adequate comprehension of the EU MDR enactment. A large portion of the obstacles organizations are confronting begin here: At an abnormal state, the industry must acknowledge the way that the take-off and translation of any broar-based control will contain components of “hazy area”. The voyage to consistency won’t occur without any forethought and slip-ups will be made by any association endeavoring to agree to the considerable rundown of MDR necessities. Having a cross-utilitarian arrangement set up that catches exercises adapted, yet in addition, verbalizes remediation and consistence endeavors will best position an association for long haul achievement.

Taking a gander at the test, what should be possible presently is that the present Medical Device Directive (93/42/EEC) has 20 articles and 12 attaches, and the Medical Device Regulation (EU 2017/745) has 123 articles and 17 Annexes. It is in this way, basic to fabricate a cross-useful group and appoint suitable staff individuals to peruse and break down various parts of the law. Further, since the majority of these people will probably be administrative or quality experts, they should almost certainly “make an interpretation of” controls into language that resounds with various gatherings of people, especially with regards to increase comprehension and verifying responsibility from the C-suite initiative.

The Long-run that will be considered is EU MDR isn’t an independent direction yet is indispensably snared with other required affirmations. It is, thusly, of worry that most organizations appear to be tested by the need to deal with numerous consistence endeavors in the meantime. For instance, since EU MDR accreditation is simpler to acquire when consistency with specific parts of ISO 13485:2016 have been accomplished, it is shrewd to seek after consistency with the two necessities couple. But then, practically 50% of overview members have not yet accomplished ISO affirmation to the present standard, of which 42% were fair sized organizations and 43% were little organizations. Actually, there are sufficient covering necessities between the two – eg. Business system and procedure changes, just as language and reference modifications – that seeking after them at the same time will probably be increasingly effective in the long haul.

 

Read Continue on https://www.operonstrategist.com/blog/the-channel-to-eu-mdr-compliance/

ULTIMATE GUIDE ON MEDICAL DEVICE REGISTRATION IN 7 DIFFERENT COUNTRIES

This is the most comprehensive guide for every manufacturer who wants to register their medicinal product in different countries all around the globe.

Let’s check regulation and certification for different countries all over the globe which helps you to market your product globally.

MEDICAL DEVICE REGISTRATION IN 7 DIFFERENT COUNTRIES:

• Medical Device Registration in India
• Medical Device Registration in Saudi Arabia
• Medical Device Registration in Algeria
• Medical Device Registration In Thailand
• Medical Device Registration In Ireland
• Medical Device Registration In Singapore
• Medical Device Registration In Brazil

Read More: https://www.operonstrategist.com/medical-device-registration/

Final Orders on 6 Medical Device Classifications are pointed by CDRH

A set of final orders issued by the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) on Thursday established new classifications for six device types.

The final orders cover devices indicated for use in surgery, ophthalmology, anesthesiology and neurology, and classify five new device types into class II (special controls) and one into class I. The classifications were developed based on the de novo classification requests CDRH received and granted in 2017 and 2018, with the exception of one 2009 submission that was not granted until 2012.

Read More: https://www.operonstrategist.com…

US FDA SETS PILOT TO EXPAND SPECIAL 510(K) MARKET PATHWAY

Medical device regulators at the US Food and Drug Administration has commenced a new pilot program for expanded suitable in the agency’s Special 510(k) pathway, prospectively relieve market compliance necessity for more manufacturers whose devices have undergone into changes.

FDA’s Special 510(k) Program Pilot would authorize more types of changes to the registered devices to qualify for the simplified Special 510(k) pathway, planned for simplified regulatory clearance of changes to devices that have already obtained premarket notification. All the Special 510(k) submissions to FDA from October 1, 2018, will be examined for addition in the pilot, with the goal of increasing overall utilization of this 510(k) route.

Read More: US FDA Sets Pilot to Expand Special 510(k) Market Pathway

FDA Updated Premarket Cybersecurity Guidance for Medical Device Manufacturers

The Food and Drug Administration (FDA) updated premarket cybersecurity guidance to the healthcare industry that updates cybersecurity recommendations for medical device manufacturers with the aim of addressing vulnerabilities and evolving cybersecurity threats.

The draft premarket cybersecurity guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, identifies issues related to cybersecurity that manufacturers should address in the design and development of medical devices to ensure better protection of devices against cybersecurity threats that could interrupt clinical operations and delay patient care.

https://www.operonstrategist.com/fda-updated-premarket-cybersecurity-guidance/

US FDA’S REGULATORY GUIDANCE PLANS FOR 2019 | MEDICAL DEVICE DIVISION

US FDA’s Regulatory Guidance Plans for 2019 | Medical Device Division

Overhaul cybersecurity necessity for medical device premarket submissions, Abbreviated and Special 510(k) program clarification, and medical software policy changes having its origin from the 21st Century Cures Act rank highly between topics for a new record of guidance documents the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) plans to produce during the agency’s 2019 fiscal year.CDRH’s new record of final guidance under evolution for 2019 reflects the division’s primary issues in terms of public health and increasing regulatory process planning based on available resources. Advance guidance documents have been assembled into higher-priority (A-List) and lower priority (B List) groups.

Broad topics such as updates to CDRH’s cybersecurity regulatory point of view, Least Burdensome Provisions and benefit-risk determination factors as well as program-specific guidelines layering 510(k), Unique Device Identification (UDI) and other policies transcend the center’s list for the coming fiscal year.

Further high-priority draft guidances planned for the 2019 fiscal year address issues including:

Top-priority CDRH guidance topics for 2019

Read More: http://operonstrategist.com/news_updates/us-fdas-regulatory-guidance-plans-for-2019-medical-device-division/

Click Here to get FDA 510(k) for your medical device

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CDSCO Guideline Approved for Medical Devices Safety & Performance

The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. One of the major functions of CDSCO is approval of new drugs in the country. During the month of March 2018, CDSCO guideline was approved on the following issuance of the guidelines under the provisions of the Medical Devices Rules, 2017 on Essential Principles for safety and performance of medical devices CDSCO.

Read More: https://www.operonstrategist.com/cdsco-guideline

Ultimate Guide on FDA QSR Compliance for medical device manufacturers

The medical device industry in the US is highly regulated, as medical product supplied can pose a great threat to health and safety of humans. The US FDA is the leading regulatory body in the world that has established certain frameworks and regulations to which the medical device manufacturers need to be compliant with for their approval or clearance. FDA has set Quality System Regulation (QSR) specifying current Good Manufacturing Practices (cGMP) for medical devices in the industry. Manufacturers developing and supplying medical devices to the U.S. are expected to maintain these stringent quality management systems and be compliant with the code of Federal Regulations 21 CFR 820. Here the system covers a broad range of areas, including production and process controls, corrective and preventive actions, product development and management. Manufacturers must adhere to quality systems and ensure that their products consistently meet the requirement as specified by the FDA. Manufacturers supplying medical devices to the US must have a complete knowledge and understanding of the regulations and QSR compliance pertaining to medical devices.  Since the medical device industry in the US is a compliance and regulation driven industry, the manufacturers must be aware of various medical device regulations and frameworks.

Read More: https://www.operonstrategist.com/fda-qsr-compliance-for-medical-device-manufacturers/

FDA’s medical device cybersecurity program | FDA Commissioner

The threat of cyber attacks is no longer theoretical. Cybercriminals and adversaries can inflict significant harm on networks through relatively simple methods, like emails or bugs known as malware. In recent years, we’ve witnessed the far-reaching and negative consequences of successful cyber campaigns on organizations so-called cybersecurity. Victims include financial institutions, government agencies, and now healthcare systems. Even when medical devices are not being deliberately targeted, if these products are connected to a hospital network, such as radiologic imaging equipment, they may be impacted.

As the number of cyber attacks has increased, we’ve heard concerns about the potential for cybercriminals to attack patient medical devices. Cybersecurity researchers often referred to as “white hat hackers” have identified device vulnerabilities in non-clinical, research-based settings. They’ve shown how bad actors could gain the capability to exploit these same weaknesses, thereby acquiring access and control of medical devices. The FDA isn’t aware of any reports of an unauthorized user exploiting a cybersecurity vulnerability in a medical device that is in use by a patient. But the risk of such an attack persists. And we understand that the threat of such an attack can cause alarm to patients who may have devices that are connected to a network. We want to assure patients and providers that the FDA is working hard to be prepared and responsive when medical device cyber vulnerabilities are identified.

READ MORE : https://www.operonstrategist.com/fda-commissioner-statement-on-fdas-medical-device-cybersecurity-program/

International Medical Device Standards – ISO 13485 and ISO 14971

The term medical device covers a vast range of equipment, from simple tongue depressors to haemodialysis machines. Like medicines and other health technologies, they are essential for patient care – at the bedside, at the rural health clinic or at the large, specialized hospital. The International Medical Device Standard is something that is used for the mapping of technical issues and concerns, with regard to regulatory aspects of standards developed by some major international standardization committees.

Medical devices are subject to strict general controls and procedural regulations.  The development and use of standards is vital to ensuring the safety and efficacy of medical devices.  Numerous regulatory agencies and standards organizations collaborate to establish the accepted standards for medical equipment.  Standard‐setting activities include the development of performance characteristics, testing methodologies, manufacturing practices, product standards, scientific protocols, compliance criteria, ingredient specifications, labeling, or other technical or policy criteria.

International Medical Device Standards

There are two associations that normally issue global models: the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).

These guidelines are global norms, which means they apply to the world. Therefore, some random locale or nation could receive them, maybe with adjustments or impediments.

Universal benchmarks are indicated, normally, with three sections. First is the issuing association, second is a number, and the third is the time of issue. For instance, ISO 14971:2007 is a universal standard that ISO issued in 2007. The title is Medical gadgets — Application of hazard administration to medicinal gadgets.

 

A local or a nation has a guidelines association that may embrace the global standard, and at times they alter it or place constraints on it. Furthermore, the medicinal gadget experts in the district or nation may perceive the standard, yet there is no commitment to do as such. We will utilize the U.S., EU, and Canada to outline these focuses.

United States

In the U.S., the measures association is the American National Standards Institute(ANSI). It is the U.S. delegate to ISO. ANSI is made out of different U.S. associations that may wind up engaged with embracing American national norms. Two essential associations here are the Association for the Advancement of Medical Instrumentation (AAMI) and the American Society for Quality (ASQ).

At the point when ANSI receives a standard, the associations included appearing as a prefix. In the U.S. our precedent benchmarks are:

• ANSI/AAMI/ISO 13485:2003 (R2009), Medical gadgets — Quality administration frameworks – Requirements for administrative purposes
• ANSI/AAMI/ISO 14971:2007 (R2010), Medical gadgets — Application of hazard administration to therapeutic gadgets

ANSI has an arrangement to audit models all the time. On the off chance that the standard is reaffirmed, that date, with a “R”, takes after the underlying date.

Another outstanding standard is ANSI/ISO/ASQ Q9001-2008: Quality administration frameworks — Requirements, which is the U.S. rendition of ISO 9001:2008.

The U.S. benchmarks association may embrace a standard, yet the U.S. therapeutic gadget administrative specialist, the Food and Drug Administration (FDA), doesn’t need to remember it. The FDA keeps up a rundown of perceived accord norms for therapeutic gadgets. That rundown incorporates:

• ISO 14971:2007, Medical gadgets — Application of hazard administration to therapeutic gadgets
• ANSI/AAMI/ISO 14971:2007 (R2010), Medical gadgets – Application of hazard administration to therapeutic gadgets

Fundamentally, it does exclude either the worldwide or U.S. forms of 13485, in light of the fact that FDA requires an alternate quality administration framework for restorative gadgets promoted in the U.S.

For Market Your Medical Device Internationally CONTACT US

European Union

 

The EU has two gauges association that are important for this situation: the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC). Consider CEN the EU association that compares with ISO, and CENELEC as relating with IEC.

At the point when CEN issues a standard in view of an ISO standard, it includes the prefix “EN” and changes the year in like manner. In the EU our precedent norms are:

• EN ISO 13485:2012, Medical gadgets — Quality administration frameworks — Requirements for administrative purposes
• EN ISO 14971:2012, Medical gadgets — Application of hazard administration to medicinal gadgets

CEN issues gauges, however, does not offer them. Duplicates come through assigned deals focuses, which are the national guidelines associations in the EU part states. Every one of these benchmarks associations includes its own particular prefix. For our precedents, the United Kingdom adaptations are accessible from BSI (British Standards Institution) as British benchmarks and move toward becoming:

• BS EN ISO 13485:2012
• BS EN ISO 14971:2012

Additionally, for Ireland NSAI (National Standards Authority of Ireland) offers:

• I.S. EN ISO 13485:2012
• I.S. EN ISO 14971:2012

The EU has an arrangement of item orders that characterize the fundamental prerequisites for the specific kinds of items. For this situation, the appropriate mandates are the Medical Device Directive (MDD), the Active Implantable Medical Device Directive (AIMDD), and the In Vitro Diagnostic Directive (IVDD). A few norms have exceptional status with respect to the orders — they are blended. Harmonization offers a legitimate “assumption of congruity,” implying that usage of the blended standard demonstrates the gadget adjusts to that piece of the Essential Requirements in the mandate.

A standard ends up blended to a mandate after production in the Official Journal of the European Union. Furthermore, the EU keeps up an enlightening site for every item order posting the orchestrated benchmarks.

The EU expresses that the item orders for medicinal gadgets are more prohibitive than the universal guidelines. Therefore, the EU renditions clarify why following the worldwide measures won’t fulfil the item orders.

Canada

In Canada, the guidelines association is the Canadian Standards Authority (CSA). For our model gauges, the Canadian adaptations are:

• CAN/CSA-ISO 13485-03 (R2013), Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes
• CAN/CSA-ISO 14971-07 (R2012), Medical Devices — Application of Risk Management to Medical Devices

The administrative specialist for therapeutic gadgets is Health Canada, which distributes a rundown of perceived benchmarks for restorative gadgets.

The perceived principles, in view of our precedents, are:

• CSA-ISO 14971-07, Medical gadgets — Application of hazard administration to restorative gadgets
• ISO 14971:2007, Medical gadgets — Application of hazard administration to restorative gadgets

For most restorative gadgets sold in Canada, the maker must have a testament expressing that the quality administration framework under which the gadget is made fulfils National Standard of Canada CAN/CSA-ISO 13485:03, Medical gadgets — Quality administration frameworks — Requirements for administrative purposes.

Standards are easy to understand if you keep a few simple concepts in mind. To start with, recollect the arrangement of prefixes. On the off chance that you say a standard, make sure to incorporate the right prefixes. They change contingent upon the territorial or national application.

# Second, make sure to incorporate the year, since it is a huge part of the assignment.

# Third, models may change in light of the national or provincial controls. For instance, in the EU we realize that ISO 14971:2007 does not fulfil the item mandates; gadget producers actualize EN ISO 14971:2012.

# Fourth, nations or locales don’t embrace measures from another nation or area. For instance, the U.S. won’t embrace EN ISO 14971:2012. One reason is that it incorporates particular necessities from the EU item mandates that don’t matter to gadgets showcased in the U.S.

Operon Strategist is a medical device regulatory consultancy company which provides regulatory advisory & guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers.

Operon Strategist has expertise in handling Medical Device Turnkey Projects all around the world. And have experience of setting up small, medium and large medical device manufacturing facility in every domain of medical devices. We have an impressive portfolio with existing industry giants which makes us competent for undertaking any project.

We ensure your manufacturing unit is suitable for all National/International regulatory norms and expected audits.

Operon Strategist has all experience and expertise in handling the project related to International Medical Device Standards. As we already have completed and have some project in progress at various global locations. Our Online Screen Sharing module facilitates effective training of the individuals of the organization. Projects deliverables and timelines are tracked/handled through meticulous planning by our team.