Technical documentation for Devices

Our Medical Writer have Enriched Knowledge to prepare TD documents in assessment for biological hazards, risk characterization and toxicological risk assessment while also meeting the test requirements of varying international marketplaces and geographies. With evidence for the medical device to ensure the general safety and efficacy under class section and also as it determines criteria for a TD for post-market surveillance.

Our Expertise

• Product description including any variants
• Explanation of Novel Features
• Manufacturing specification
• Risk management- documentation
• Process validation
• Compatibility studies