Accurate and complete technical documentation is essential for obtaining regulatory approvals, such as CE marking or FDA clearance, and for maintaining market access. Incomplete technical documentation leads to delays in product clearance and therefore market access. In the survey published in February 2024 by EC, the notified bodies communicated that 17% of the submitted documentation was incomplete. The challenges include understanding and interpreting complex regulatory requirements, maintaining up-to-date documentation, and ensuring that all necessary information is included (a.k.a. completeness check). Writing and assessing technical documentation effectively is crucial for achieving compliance and facilitating successful regulatory submissions.
Our services for medical device technical documentation encompass both writing and gap assessment to ensure your documentation meets regulatory requirements and supports successful market entry.
We provide the following tailored services:
We handle technical documentation in multiple ways
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Approach & Expertise
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- Our lean and powerful team with degrees in pharmacy, chemistry, biology, or related studies strive to be of added value to you. Our short reporting lines enable the most efficient road to your success.
- Having one point of contact from our experts backed by the team’s collective knowledge and resources we give reliable advice and execute projects seamlessly.
- At Starodub, consistency and assurance of quality are vital. A quality management system has been implemented and we adhere to GxP and ISO 9001/13485.