PRODUCT TECHNICAL DOCUMENTATION
THE IMPORTANCE OF TECHNICAL DOCUMENTATION
When a medical device is manufactured, its intended use, components, functions, and potential risks must be specified. NewMed Consulting also supports you in this process, helping you draft the technical product documentation in accordance with Annexes II and III of Regulation (EU) 2017/745 (MDR).
The drafting of these documents must be supported by adequate planning, for which an in-depth knowledge of the subject and the regulations required is necessary. Our company has specialized in the drafting of these documents and is ready to support you throughout the entire process that follows your medical device production.
To learn more about the technical documents that are essential for your business, contact us today!
European Commission
EU Regulation 2017/745 MDR
Italian Ministry of Health
Drafting of Technical Documentation according to Annex II and III of EU Regulation 2017/745 for:
- Non-active medical devices
- Medical devices produced in a Clean Room and/or subjected to cleaning processes
- Medical devices placed on the market in sterile conditions
- Medical devices made of plastic or metal alloys
- Disposable or reusable medical devices
- Medical devices subject to reprocessing
- Implantable medical devices
- Medical devices based on substances
- Active medical devices
Drafting of the Risk Management Plan and Report
Clinical evaluations and drafting of Clinical Evaluation Protocols and Reports (CEP/CER)
Drafting of the Summary of Safety and Clinical Performance (SSCP)
Issuance of Biological Evaluation Protocols and Reports (BEP/BER)
Issuance of Usability Protocols and Reports based on a risk management approach
Issuance of studies and protocols for the reprocessing of reusable medical devices based on a risk management approach
Issuing specific rationales
Development and issuance of IQ, OQ, PQ protocols for the validation of critical / special production and control processes
Statistical methods and trend analysis
Drafting and issuing of the Post Market Surveillance Plan (PMS Plan), the Periodic Safety Update Report (PSUR) and the Post Market Clinical Follow-up (PMCF)
PROTOCOLS: DEVELOPMENT AND EMISSION
Among the technical documents that our company can help you draft, there is also the drafting of plans and protocols, which are strictly necessary in the medical field. In order to obtain and above all, maintain European Union approval for the marketing of your medical device, there are several mandatory protocols, including CEP/CER (Clinical Evaluation Plans and Reports) and BEP/BER (Biological Evaluation Plans and Reports).
NewMed Consulting is committed to staying up-to-date with the latest regulations, documents, and protocols. The medical field is subject to stringent regulations that must be met, requiring specialized expertise. Over the years, our company has developed this expertise, making us one of the most experienced in industry.
Discover these and all the other protocols by contacting us now!
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