Regulatory Requirements

June 29, 2018

Notes From the Field – The Drug/Device Combination Product Summit

We recently had the opportunity to speak at the Combination Product Life Cycle Management Summit, which was held in Boston earlier this month. Our co-founder and COO, Phil Burke, presented best practices for developing a dedicated, medical device designed to deliver a therapeutic drug. In attendance were quality, regulatory and device strategy/management professionals from a veritable Who’s Who of Big Pharma. The drug/device combination products market is, in many ways, still relatively nascent. It’s also […]
July 27, 2017
REV.1 Engineering 3 Pillars of Medical Device Development

The Third Pillar of Medical Device Engineering: Compliance Certification

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 […]
July 11, 2017
Medical Device Development - Quality Engineering

The Second Pillar of Medical Device Engineering: Creating an Effective Quality System

In our last blog, we explored Design Control – the first of three pillars that support quality medical device development. The second pillar is the creation of a Quality System. This pillar is instrumental in meeting regulatory requirements to FDA and CE Mark agencies requiring compliance to ISO 13485 – Medical Devices Quality Management System and ISO 9001 – Quality Management System. Regulatory entities require that the framework of a quality system be compliant to […]
February 22, 2017

Bending Medical Device Regulations?

At Rev.1 we pride ourselves in getting you to your project goals 2x Faster.  Typically, when we meet with clients for the first time, there are dozens of ways to speed up their project plan.  Cutting corners by breaking the law is NOT one of them. With a thorough knowledge of device regulations, we guide clients along the most efficient path through them.  Over the years, we have occasionally encountered a client who doesn’t fully understand […]
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