Medical Device Safety Testing and Consulting Services
Speed Up Your Regulatory and Safety Approvals
Solutions... Approvals... Training...
Expert, Responsive Engineers -- over 30 years of compliance and industry experience
We know what works; the pitfalls to avoid
Design for compliance
Your risk, usability, and software development processes in compliance
Medical device safety testing -- Fully equipped Boston based laboratory
Test reports that support FDA, CE Mark, and OSHA NRTL/Can Certification -- accredited as a TÜV Rheinland Partner Test Laboratory
Close partner network for other needed services: EMC, Shock & Vibration, Transport, Ingress, Ultrasound, Light, Quality Systems
Let us help you with your medical device development -- the earlier, the better.
Frank O'Brien to Speak at NPSS Jan 22, 2014The Northeast Product Safety Society (NPSS) chapter, of the IEEE
Product Safety Engineering Society, will be hosting a regular meeting with a technical
users; improve device safety ...
Posted Jan 8, 2014, 1:31 PM by Debra Carlson
It's all about the User InterfaceImprovements in your medical device user interface will result in real improvements in safety. This was Frank O'Brien's message during his talk at MedTech, Ireland in October. The ...
Posted Nov 2, 2013, 5:20 AM by Frank O'Brien
Shocktober Open House 2013Thursday October 24th 2013, 4-8 pm
Don't get burned -- Be prepared
All are welcome!HEAR Local network of test partners explain recent updates to regulatory and safety requirements ...
Posted Oct 8, 2013, 1:29 PM by Frank O'Brien