Regulatory Requirements

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 […]
September 22, 2016

The 3 R’s: Research, Regulation, Reimbursement

In our last blog, we laid out 5 pre-funding essentials for early start-ups. Today we want to delve further into three critical topics. Each has special significance not just at the pre-funding stage, but throughout the development cycle. 1) Research – Good research is the foundation of your medical device, but you don’t just need top-notch technical research. You need to thoroughly understand the market your product is designed to reach. Even if your initial […]