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The Third Pillar of Medical Device Engineering: Compliance Certification

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So far we’ve discussed two of the three key pillars of quality medical device engineering: Design Control and Quality System. The third, Compliance Certification, is the audit of the design controls and quality system, and is therefore heavily dependent on successful implementation of the first two pillars.

Many medical device companies feel anxious when it comes to certification – and for good reason. While everyone is aware of the long check list the certification agencies audit, it’s hard to tell what specific area they might focus on for any given device. Some may be heavy on design control, others heavy on transfer to manufacturing, so your certification peace of mind will only come when you have all areas of your development solidly documented.

It also helps to have a confident design team you can rely on to answer specific agency questions. FDA, CE or ISO certification, your medical device engineering team must have the experience necessary to give the appropriate detail needed. With a robust quality system in place, you can rest assured that the complete design history and precise documentation will be available when it comes time for certification.

While manufacturers are separately audited by the certification agencies, these audits rely heavily on the design documentation from the R&D team. Design transfer has to be certified, ensuring that protocols are followed for equipment calibration, grade of materials, and design components. As part of REV.1 Engineering’s full service for medical device engineering, we work with the manufacturer to be certain every item is matched one-to-one.

Audit preparedness for your medical device will include one or more of the following certifications:

ISO 9001 – This is the International Standards Organization’s specific requirements for a quality management system (QMS).

ISO 13485 – Medical quality system registration – these standards were updated in 2016 after more than a decade, and the deadline for compliance with the new standards checklist is coming right up in 2019.

CE Mark – There is a European National version of the ISO standard: EN ISO 13485:2012. This is the official harmonized version of the standard, and certification to EN ISO 13485 presumes compliance with the applicable European New Approach Directives.

FDA Registration – Also known as the QSR, the FDA 21 CFR part 820 outlines Current Good Manufacturing Practice (CGMP) regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.

Local State Agencies – Depending on the type of medical device, certain states may have more stringent regulations than the FDA, and these need to be prepared for as well.

While knowing the ins and outs of each compliance standard is critical, it’s just as important that your design team understands what’s required – and what’s not required. This will help you avoid unnecessary delays in bringing your medical device to commercialization.

REV.1 Engineering brought Ablative Solutions Inc. through the entire design control process, resulting in FDA approval. We also implemented their quality system, set up a cloud-based electronic design database, and prepared them to successfully gain approval in their ISO 13585 audit. If you’re looking for a full-service medical device engineering team that can move you toward audit approval – even if you’ve failed earlier attempts – give us a call at 951.696.3933, connect with us on LinkedIn, or send us an email at Let’s get your audit approved so you can commercialize and profit from your novel medical device.