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March 14, 2023

Maximize Your Chances with the EU MDR:
Secure Your Future with an EU MDR Course

Attention all medical device manufacturers and professionals! 

On January 6th of 2023, the European Commission released a proposed deadline extension for certifying your medical devices, giving you a much-needed breathing space to comply with the Medical Devices Regulation (EU MDR). The provisions of the extension, if put into law, will depend on the medical devices’ risk class, ensuring that patients continue to have access to essential medical devices while maintaining the highest standards of safety and performance.

The EU MDR aims to provide a high level of health protection for patients and users, and to ensure the seamless functioning of the internal market for medical devices. As a manufacturer, you must make sure that your products meet the stringent requirements of the EU MDR to continue selling in the EU market. With the proposed extension, you have more time to get your processes and systems in order, but you must act fast.

Here are the key highlights of the EU MDR deadline extension proposal:

A. Higher-risk devices can have their transition period extended from May 26, 2024 to December 31, 2027, and medium and lower-risk devices can have their transition period extended until December 31, 2028.

B. Class III implantable custom-made devices can have their transition period extended until May 26, 2026, subject to the manufacturer’s application for a conformity assessment before May 26, 2024.

C. The validity of certificates issued up until May 26, 2021 will be extended.

D. The “sell-off” date will be removed to ensure the continued availability of safe and essential medical devices that are already on the market.

However, to take advantage of this extension, certain conditions must be met to ensure the safety of devices and steps taken by manufacturers to comply with the new regulations. Devices may only be placed on the market or put into service until the dates referred to in the extension proposal if the following conditions are met:

  1. The devices continue to comply with Directive 90/385/EEC or Directive 93/42/EEC, as applicable.

  2. There are no significant changes in the design and intended purpose.

  3. The devices do not present an unacceptable risk to the health or safety of patients, users, or other persons, or to other aspects of the protection of public health.

  4. No later than May 26, 2024, the manufacturer has put in place a quality management system in accordance with Article 10(9).

  5. No later than May 26, 2024, the manufacturer, or an authorized representative, has lodged a formal application for conformity assessment in respect of a device referred to in the extension proposal or in respect of a device intended to substitute that device, and no later than September 26, 2024, the notified body and the manufacturer have signed a written agreement.

  6. The manufacturer’s QMS continues to comply with the requirements of the EU MDR related to post-market surveillance, market surveillance, vigilance, registration of economic operators, and of devices.

 

To ensure the quality, safety, and performance of your medical devices and keep them on the EU market, it’s essential to understand the EU MDR and how to transition your processes under the Quality Management System (QMS) to meet the regulation.

Invest in yourself and your company by enrolling in our EU MDR 101 course, which provides comprehensive training on the EU MDR, its requirements, and how to transition to the new regulation smoothly. Don’t miss this opportunity to gain the knowledge and skills necessary to comply with the EU MDR and continue selling your medical devices in the EU market.

Enroll now: EU MDR 101: Introduction, Overview, and Implementation Process of the EU MDR (2017/745) | MDR Consultants Inc.

About The Author:

Isabel Osorio is the president and founder of MDR Consultants Inc. , a medical device consulting firm specializing in regulatory and quality consulting services for the medical device industry. She is a former member of industry following a 16-year career in the medical device field, where she gained extensive experience as an Engineer, a Lead Auditor and a Certified Trainer for Notified Bodies, and as a medical device consultant. While working on the front lines as a Clinical Specialist years ago, a chance encounter opened her eyes to the detrimental effects of companies skipping past proper quality controls and procedures.

This experience changed her perspective on the importance of Medical Device Standards and Regulations forever and inspired her to focus her career on helping medical device companies and professionals better understand the requirements to ensure confidence and competence in their implementation of relevant requirements. Product malfunctions can have harmful effects on someone’s life, including death, and that patient could be you or a loved one. That is why patient safety is at the heart of her MDR Consultant’s mission to provide best-in-class training and consulting services. You can reach her at info@mdrconsultants.com

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March 10, 2023

The Positive Aspects of having Regulatory Requirements in the
Medical Device Industry.

Regulatory requirements are often seen as a burden in the medical device industry. However, these requirements play a crucial role in ensuring the safety and effectiveness of medical devices for patients and healthcare providers.

Here are some of the positive aspects of having regulatory requirements in the medical device industry:

1. Patient safety

The primary goal of regulatory requirements is to ensure that medical devices are safe for patients to use. This includes ensuring that devices meet standards for design, manufacture, and performance, as well as ensuring that devices are accurately labeled and properly tested prior to release.

2. Improved quality of medical devices

Regulatory requirements also promote the quality of medical devices by establishing strict standards for their design, manufacture, and performance. This helps to ensure that medical devices are reliable and effective, and that they perform as intended.

3. Better healthcare outcomes

By ensuring the safety and effectiveness of medical devices, regulatory requirements can contribute to better healthcare outcomes for patients. This can result in improved health, faster recoveries, and a higher quality of life for patients.

4. Protection of healthcare providers

Regulatory requirements also help to protect healthcare providers by ensuring that medical devices are safe for them to use and that they are not exposed to unnecessary risks.

5. Facilitation of medical device innovation

Regulatory requirements also play a role in facilitating medical device innovation by creating a framework for the development and commercialization of new devices. This helps to ensure that new devices are safe and effective, and that they meet the needs of patients and healthcare providers.

Conclusion

In conclusion, regulatory requirements in the medical device industry play a critical role in ensuring the safety and effectiveness of medical devices for patients and healthcare providers. By promoting quality and innovation, regulatory requirements can help to improve healthcare outcomes and protect both patients and healthcare providers.

About The Author:

Isabel Osorio is the president and founder of MDR Consultants Inc. , a medical device consulting firm specializing in regulatory and quality consulting services for the medical device industry. She is a former member of industry following a 16-year career in the medical device field, where she gained extensive experience as an Engineer, a Lead Auditor and a Certified Trainer for Notified Bodies, and as a medical device consultant. While working on the front lines as a Clinical Specialist years ago, a chance encounter opened her eyes to the detrimental effects of companies skipping past proper quality controls and procedures.

This experience changed her perspective on the importance of Medical Device Standards and Regulations forever and inspired her to focus her career on helping medical device companies and professionals better understand the requirements to ensure confidence and competence in their implementation of relevant requirements. Product malfunctions can have harmful effects on someone’s life, including death, and that patient could be you or a loved one. That is why patient safety is at the heart of her MDR Consultant’s mission to provide best-in-class training and consulting services. You can reach her at info@mdrconsultants.com

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March 05, 2023

The Benefits of the Medical
Device Single Audit
Program (MDSAP)

Introduction

The Medical Device Single Audit Program (MDSAP) was created to streamline the regulatory approval process for medical device companies that operate in multiple jurisdictions. The program aims to provide a single audit process for regulatory agencies, reducing the time and costs associated with multiple audits and ensuring that medical devices meet regulatory requirements globally.
 

Below are the key benefits of the Medical Device Single Audit Program (MDSAP) :

Benefit 1 : Single Point Of Contact For Regulatory Approval.

One of the key benefits of the MDSAP program is that it provides medical device companies with a single point of contact for regulatory approval. Instead of having to undergo separate audits by each regulatory agency, companies can now participate in a single audit process that covers all regulatory requirements in the participating countries. This reduces the time and costs associated with multiple audits and ensures that regulatory approval is obtained in a timely manner.
 
 Benefit 2 : Comprehensive Understanding Of Regulatory Requirements.
One of the key benefits of the MDSAP program is that it provides medical device companies with a single point of contact for regulatory approval. Instead of having to undergo separate audits by each regulatory agency, companies can now participate in a single audit process that covers all regulatory requirements in the participating countries. This reduces the time and costs associated with multiple audits and ensures that regulatory approval is obtained in a timely manner.

Benefit 3 : Ensuring Regulatory Compliance With The MDSAP Program.

 In addition, the MDSAP program helps medical device companies to ensure that their products meet regulatory requirements in multiple jurisdictions. This includes guidance on regulatory submissions and the preparation of required documentation. This helps companies to avoid costly errors and delays in the approval process, ensuring that their products can be brought to market efficiently and effectively.

Benefit 4 : Improving Quality Management Systems With MDSAP Program

One of the key benefits of the MDSAP program is that it provides medical device companies with a single point of contact for regulatory approval. Instead of having to undergo separate audits by each regulatory agency, companies can now participate in a single audit process that covers all regulatory requirements in the participating countries. This reduces the time and costs associated with multiple audits and ensures that regulatory approval is obtained in a timely manner.
 

Benefit 5 : Staying Ahead Of The Competition With The MDSAP Program

 
Finally, the MDSAP program helps medical device companies to stay ahead of the competition. The program provides companies with access to the latest information and best practices in the medical device industry, helping them to stay ahead of the curve and stay competitive in the global market.

Conclusion

The Medical Device Single Audit Program (MDSAP) provides medical device companies with a number of benefits, including a single point of contact for regulatory approval, a comprehensive understanding of regulatory requirements, and improved quality management systems. Companies that participate in the MDSAP program are better positioned to succeed in the competitive medical device market and bring their products to market efficiently and effectively.

About The Author:

Isabel Osorio is the president and founder of MDR Consultants Inc. , a medical device consulting firm specializing in regulatory and quality consulting services for the medical device industry. She is a former member of industry following a 16-year career in the medical device field, where she gained extensive experience as an Engineer, a Lead Auditor and a Certified Trainer for Notified Bodies, and as a medical device consultant. While working on the front lines as a Clinical Specialist years ago, a chance encounter opened her eyes to the detrimental effects of companies skipping past proper quality controls and procedures.

This experience changed her perspective on the importance of Medical Device Standards and Regulations forever and inspired her to focus her career on helping medical device companies and professionals better understand the requirements to ensure confidence and competence in their implementation of relevant requirements. Product malfunctions can have harmful effects on someone’s life, including death, and that patient could be you or a loved one. That is why patient safety is at the heart of her MDR Consultant’s mission to provide best-in-class training and consulting services. You can reach her at info@mdrconsultants.com

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March 03, 2023

Medical Device Validation
Requirements, Key Aspects
to Remember.

In the process of assessing over one thousand companies in the medical device field I notice several prevalent process deficiencies. One of them, was related to the misinterpretation of the validation requirements as applied to different areas of the quality management system. As we know, must of the regulatory requirements rely heavily in the provisions of ISO 13485. Naturally, we should review and implement the validation requirements defined in this standard and then, as applicable, add regulatory requirements and product specific requirements. There are several sections within the standard that we need to reference. These include:

  • Section 7.1(c) with title planning of product realization,
 
  • Section 7.5.6 with title validation of processes for production and service provisions,
 
 
  • Section 4.1.6 with title Quality Management System general requirements, 
 
  • Section 7.6 with title Control of monitoring and measuring equipment.
 
  • Sections 7.3.2 and 7.3.7 with titles design and development planning and design and development validation,
 
  • Section 7.5.7 with title particular requirements for validation of processes for sterilization and sterile barrier systems, if applicable
 
 

Our Focus:

Our focus should always be Section 7.5.6, paragraph 3, which defines the requirements for the process presented in a prescriptive list of specified content requirements. One of the most common nonconformity found in medical device organizations is the lack of consideration of these content requirements in other areas where validation of processes is performed. For example, as part of the design and development process, we have a requirement to meet the provisions of requirements listed in 7.3.2 that references the requirements of an organization to control and plan the design and development processes of products and shall document, maintain, and update the validation activities that are appropriate at each design and development stage. Yet when these plans and reports are reviewed, they, more often than not, do not include all sections defined in 7.5.6.

Therefore, to avoid this very common nonconformity, always remember that when you are designing or revising your medical device quality management system validation procedures and validation plans and reports templates, you must ensure that they address and includeall the requirements defined in paragraph 3 of section 7.5.6 as minimum requirements. It is also highly recommended to add a mandatory additional level of review and inclusion of all applicable quality managements system related regulatory requirements and all other external product specific documents to include regulations, standards, common specifications, guidance documents, and other sources of technical requirements used in the processes under your system to produce your product(s). This way you will be certain that all your validation processes and their outputsare conformant and compliant to all applicable requirements.

About The Author:

Isabel Osorio is the president and founder of MDR Consultants Inc. , a medical device consulting firm specializing in regulatory and quality consulting services for the medical device industry. She is a former member of industry following a 16-year career in the medical device field, where she gained extensive experience as an Engineer, a Lead Auditor and a Certified Trainer for Notified Bodies, and as a medical device consultant. While working on the front lines as a Clinical Specialist years ago, a chance encounter opened her eyes to the detrimental effects of companies skipping past proper quality controls and procedures.

This experience changed her perspective on the importance of Medical Device Standards and Regulations forever and inspired her to focus her career on helping medical device companies and professionals better understand the requirements to ensure confidence and competence in their implementation of relevant requirements. Product malfunctions can have harmful effects on someone’s life, including death, and that patient could be you or a loved one. That is why patient safety is at the heart of her MDR Consultant’s mission to provide best-in-class training and consulting services. You can reach her at info@mdrconsultants.com

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March 02, 2023

Medical device manufacturers need to ensure that their products are compliant with regulatory requirements before they can be marketed and sold.

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March 01, 2023

Get a Head Start on EU MDR Compliance with our EU MDR Courses.

Are you a medical device company looking to navigate the European Union Medical Device Regulation (EU MDR) 2017/745 with ease? Look no further than our EU MDR Courses – the ultimate courses to help you understand and comply with this complex regulation.


Here Are Just A Few Of The Many Benefits Of Our EU MDR Courses:

Sign Up Now

1.Get Up to Speed Quickly

With our EU MDR courses, you’ll learn everything you need to know about the EU MDR. From the basics of the regulation to more complex requirements, you’ll be an EU MDR expert in no time.

2.Stay Ahead of the Competition

By providing your employees with the necessary knowledge and skills to meet the EU MDR requirements, you’ll be one step ahead of your competition. And who doesn’t want to be the cool kid on the block?

3.Avoid Costly Mistakes

Non-compliance with the EU MDR can result in hefty fines, legal action, and negative publicity. Our EU MDR Courses will help you understand the regulation and avoid these costly mistakes.

4.Get Personalised Attention

With our EU MDR Courses, you’ll have access to experienced professionals who can answer all of your EU MDR questions. No more endless Google searches – you’ll get the answers you need, when you need them.

So why wait? Sign up for our EU MDR today and start your journey to EU MDR compliance with confidence. Don’t let the EU MDR regulation stress you out – let our EU MDR courses help you get ahead.
For more information please visit:
Courses - Mdrconsultants

About The Author:

Isabel Osorio is the president and founder of MDR Consultants Inc. , a medical device consulting firm specializing in regulatory and quality consulting services for the medical device industry. She is a former member of industry following a 16-year career in the medical device field, where she gained extensive experience as an Engineer, a Lead Auditor and a Certified Trainer for Notified Bodies, and as a medical device consultant. While working on the front lines as a Clinical Specialist years ago, a chance encounter opened her eyes to the detrimental effects of companies skipping past proper quality controls and procedures.

This experience changed her perspective on the importance of Medical Device Standards and Regulations forever and inspired her to focus her career on helping medical device companies and professionals better understand the requirements to ensure confidence and competence in their implementation of relevant requirements. Product malfunctions can have harmful effects on someone’s life, including death, and that patient could be you or a loved one. That is why patient safety is at the heart of her MDR Consultant’s mission to provide best-in-class training and consulting services. You can reach her at info@mdrconsultants.com

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February 22, 2023

Mastering the EU MDR Transition: A Guide to MDR Transition Training

The European Union (EU) Medical Device Regulation (MDR) has replaced the Medical Device Directive (MDD) as the primary set of rules

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February 10, 2023

Medical Device Validation Requirements, Key Aspects to Remember

In the process of assessing over one thousand companies in the medical device

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October 07, 2022

5 Key Aspects to Consider when Designing the Perfect Medical Device Quality Management System for your Company

Author: Isabel Osorio, President and Owner of MDR Consultants Inc.

 

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May 13, 2021

TIP # 2: ADDRESSING THE EU MDR DATE OF APPLICATION INCONSISTENCY
Author: Isabel Osorio, President and Owner of MDR Consultants Inc.

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May 03, 2021

TIP # 1: FINDING HARMONIZED STANDARDS
Author: Isabel Osorio, President and Owner of MDR Consultants Inc.

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February 17, 2021

The transition period for the new EU Medical Device Regulation (MDR) is quickly approaching, is your company ready? MDR CONSULTANTS INC. can ensure you are fully prepared

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February 09, 2021

What is a medical device consultant? A medical device consultant is a medical device industry expert with years of hands-on experience in all aspects of the quality management system

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