Technical Documentation
Consulting
Technical documentation
Do you keep an eye on all changes and is your technical documentation up to date?
Do you have ongoing discussions with your notified body about the current state of the art and how you should evaluate and consider it?
Only a complete and continuously maintained technical documentation ensures continuous market access for your company.
Benefit from our experience and contact us. We are here to help.
Support
The TechFile Factory at your side
The technical documentation contains essential information about the development, verification, validation, manufacturing, and application of your medical device, IVD or drug-device combination.
This provides objective evidence that your product always meets the regulatory and normative requirements as well as the latest state of the art.
Therefore, you should always keep the technical documentation up to date. This requires efficient change management and thorough document control.
Our TechFile Factory is ISO 13485 certified and consists of an experienced team of permanent employees who support the evaluation, creation, and maintenance of the technical documentation for your company.
For pharmaceutical manufacturers, the TechFile Factory also offers the creation of all modules of the Common Technical Document according to Directive 2001/83/EC and current guidelines.
The result is a readable, searchable, and clearly structured technical documentation which allows you to demonstrate the conformity of your product to the relevant regulatory requirements of your target markets.
Services
Our consulting services for you!
- Update of existing technical documentation including product-specific documentation to correct deviations and nonconformities. These include, among others:
- Intended purpose and product description
- Risk management file according to ISO 14971
- Usability file according to IEC 62366-1 and 82304-1
- Software documentation according to IEC 62304
- Cybersecurity documentation according to IEC 81001-5-1
- Plan and report for clinical evaluation or performance evaluation
- Evaluation of biological safety according to ISO 10993-1
- Plan and report on post-market surveillance
- Creation of (technical) documentation according to European requirements (EU MDR, EU IVDR), US FDA requirements (510(k) and PMA) and for other international target markets
- Review of technical documentation to identify deviations
- Creation of all modules of the Common Technical Document according to Directive 2001/83/EC and current guidelines
- Support preparation of responses to feedback from Notified Bodies and regulatory authorities
- Training at your location or at our academy in Hamburg
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Contact
Contact us
Get in touch with us free of charge to discuss your individual needs and find out more details about our services.
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Let's work together to strengthen your competitive advantage, broaden your horizons and enter new markets. Click below to get in touch and take the first step.
NSF Prosystem GmbH
Beim Strohhause 17
20097 Hamburg
+49 40-668-788-199
