The continuous adaption and implementation of current norms and regulations for medical devices is a key activity for each medical device company. With a focus on their product, every medical device company has to ensure compliance with the latest norms and regulations for their field. With the publication of the ISO 13485:2016 and updated versions of the FDA 21 CFR Part 820, Risk Management has become a key driver for most of the activities to ensure compliance with this norm. Additionally, the regulations within the EU and for the European market changed in May 2017. The transition from the three directives for medical devices (MDD), active implantable medical devices (AIMDD) and in-vitro medical devices (IVDD) to the two regulations medical device regulation (MDR) and in-vitro medical device regulation (IVDR) will happen until 2019 and 2022 respectively.

Furthermore, other regulations such as the FDA regulations 21 CFR Part 11, 21CFR Part 820 and the ISO 13485:2016 got more aligned, but still some key differences exist. An essential difference exists with the Design Control procedure and the documentation required for entering the respective markets. Depending on the medical device and its classification, the FDA requires following the 510(k) or PMA application process with the corresponding documentation as Design History File (DHF), Device Master Record (DMR) and Device History Record (DHR). For a CE market entry, the focus is on the Summary Technical Documentation (STED) combined with the essential requirements for the medical device to be approved.

When it comes to audits or inspections, rameus solutions in-depth assessments and provides the services Quality AssuranceProcess Management and Audits/Inspections to prepare for these events. With the past experience, rameus solutions offers assistance for 13485:2016 audits, FDA inspections and MDSAP audits. Since an MDSAP (Medical Device Single Audit Program) audit affects the market access for multiple countries, a thorough and precise preparation is needed to cover the various countries compliance requirements. As service to prepare your company for the official audit, we offer external and independent auditor for your medical device. To ensure a smooth interaction with official bodies, we also support our clients in the interaction with notified bodies and other official bodies or authorities.

Our service in ISO 13485, 21 CFR Part 11, 21 CFR Part 820 are supported by the general management disciplines and Strategy Solutions.


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