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A survey was recently administered by ISO TC210 WG1 to obtain critical information to evaluate the experiences of key stakeholders such as, medical device manufacturers, subcontractors, suppliers, European Authorized Representatives, specialized consulting firms etc., during the ISO 13485:2016 transition. ISO TC210 is a taskforce focused on the quality and performance of medical devices. They have numerous deliverables that consist of, standards, risk management, guidance documents, usability, and quality management, to name a few.

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The issuance of the survey is to collect information on the transition experience and ensure that the design requirements implemented in the revision were met. The survey opened on October 10, 2018 and will close on November 9th, 2018, giving key stakeholders a couple more weeks to participate in the questionnaire. ISO TC210 WG1 plans to take the data collected from the survey to review at the Seoul meeting in November 2018. This review will help determine the best strategy in revising ISO 13485:2016.

ISO 13485 is an internationally agreed standard that sets out the requirements for a Quality Management System specific to the medical device industry. ISO 13485:2016 was published in February 2016 with a three year transition period commencing from March 2016 to the 28th of February 2019. Medical Device companies looking to maintain compliance in the medical device industry had to evaluate and adhere to this evolution of the standard. The recent evolution of ISO 13485 emphasizes the need for regulatory requirements and risk management to be key considerations in the future of Quality Management Systems.

For instance, the survey enquires on the adequacy and effectiveness of ANSI/AAMI/ISO 13485:2016 medical devices Quality Management Systems and their requirements for regulatory purposes. It asks questions based on sections from ISO 13485:2016 such as, clarification of concepts, process approach, relationship with ISO 9001:2015, compatibility with other management systems, and scope. In addition the survey addresses sections 4 through 8 in the revised standard, which are, Quality Management Systems, management responsibility, resource management, product realization, measurement, analysis, and improvement. It is also important to note that the survey addressed questions pertaining to the evolution of the ISO 13485 standard for software, risk management, usability, and sterilization.

The survey was constructed in an effective and concise manner with 39 questions, taking a participant 10 to 15 minutes to complete, and utilized a dichotomous scale, meaning they could be answered with a “yes” or “no.” Concurrently, participants also have the ability to recommend effective changes or amendments, if they choose to answer “no” on a specific question. Giving the stakeholders the ability to make recommendations for questions is a great way to understand what improvements need to be made to the future update of ISO 13485.

For companies looking to expand their global footprint in the medical device industry, getting certified under ISO 13485:2016 will show compliance to the international standard for the medical device industry. GMED, a well- established Notified Body (CE 0459) whose scope covers CE marking for all the Medical Device Directives (93/42/EEC, 98/79/EC and 90/385/EC), is a single source provider of Quality Management Systems certifications according to ISO 13485:2016, ISO 9001:2015 and MDSAP. Choosing a Certification Body accredited to provide ISO 13485 certification, and that is both a Notified Body (CE 0459) and Recognized Organization for MDSAP is an ideal strategy when trying to gain access into a larger market, minimizing the time and cost of using a single source provider of certifications.




Author: Jummie Moses

Jummie Moses is a marketing associate at GMED NA. She has a bachelor’s in mechanical engineering and a master certificate in global marketing management. She has previous experience in digital marketing analysis and project management and multimedia services. As a marketing associate at GMED NA she is responsible for conducting benchmarking, content writing, reporting, SEO, SEA in accordance with our strategic goals and our missions.



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