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.
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:
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 email@example.com. Let’s get your audit approved so you can commercialize and profit from your novel medical device.