Before modifying your medical device, consider how it could affect your testing plan and potentially put approvals at stake.
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.