Rob Packard

Background

About Rob Packard

We are building the best medical device quality and regulatory consulting firm for start-ups. We are a ten-person team, but we are always looking for individuals that have 510(k) submission experience. CE Marking or Canadian Licensing experience is a huge plus. 100% of our team works remotely from home or any sunny spot with reliable internet (no shoes required). If you are one of the lucky people that join our team, you will enjoy independence and autonomy without the stress of running your own business.We are a full-service QA/RA consulting firm that specializes in helping start-up medical device companies obtain 510(k) clearance, Canadian Medical Device Licensing, and CE Marking. We also help our clients establish new ISO 13485:2016 quality systems and obtain MDSAP certification. The favorite part of my job is training. Every week I am recording new training webinars and YouTube videos. I also post a blog every week on current quality and regulatory issues.I have 20 years of experience in the medical device industry and another 10 years of experience in biotech manufacturing validation and scale-up. I am a UConn graduate in Chemical Engineering. I was Director of Quality and Regulatory Affairs at four different medical device start-ups, and I was President/CEO of a laparoscopic imaging company I co-founded in 2004. My quality management system expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, I was a lead auditor and instructor for BSI - one of the largest Notified Bodies for CE Marking and MDSAP Certification.Technical Specialties: 510(k) Submissions, FDA eSTAR, Technical Writing, Public Speaking, Distance Learning, Remote Auditing, Risk Management, Design Controls, MDSAP, CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy.