A wide range of medical devices are introduced almost daily in today’s market, and established standards are constantly being redefined. Any novel device needs to undergo assessment for biological hazards, risk characterization and toxicological risk assessment. On top of that, any product development process must meet the testing requirements of various international markets. Planning for biocompatibility, then, is as much a business necessity as it is a regulatory requirement.
At NAMSA, we create biological safety evaluation plans to protect your medical device development process and keep it moving forward. We can help you:
- Communicate the plan to team members, company associates, and medical device regulators
- Leverage information that is known about the constituents of the device
- Identify and characterize biological and toxicological hazards associated with the medical device product in an effort to characterize risk
- Define a plan for ensuring biological safety
- Explain how your company uses the requirements of ISO 109931:2003 to assure biological safety
We recommend that you have a documented plan for ensuring biological safety before you initiate testing. We can take you from start to finish.
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