Testing your medical device properly and preparing a strong regulatory submission is a dynamic yet crucial part of bringing the product to the market. Put simply, the submission stage is not where most manufacturers want to gamble or guess. That’s where a qualified...
3 Regulatory Red Flags with Medical Device Changes
Before modifying your medical device, consider how it could affect your testing plan and potentially put approvals at stake.
Behind the Curtain: How ISO 10993 Impacts Testing Labs
Manufacturers are not the only ones facing challenges due to the updates to ISO 10993 and other recent regulatory changes. The evolving standards are also affecting testing labs. Previous industry projected timelines and costs are becoming less feasible with today's...
White Paper: Unknowns are Unacceptable™
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.