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EU Regulatory and Medical Device Quality System

Is your company in need of consulting services to evaluate regulatory documentation? Look no further than AF Pharma Service, a leading provider of regulatory support and expertise in medical device quality systems.

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When it comes to navigating the complexities of medical device regulations, AF Pharma goes beyond providing Technical Documents, Medical Device Quality Management Systems (QMS), Registrations, and EU Regulatory support. We also offer expert medical device consulting services to assist your company in evaluating the type of device and determining any necessary regulatory documentation.

 

Whether you need guidance on classification, clinical evaluations, or general medical device quality and regulatory strategy, AF Pharma's experienced consultants are ready to provide comprehensive support. Don't hesitate to reach out to AF Pharma for expert advice and personalized solutions. Our consultancy services will ensure medical device regulatory compliance and successful market entry for your medical device. We will help you with the Regulatory support needed for the EU market.

Technical File generation

  • What is an EU Medical Device Technical File?

An EU medical device technical file is a set of documents that describes a device. It must prove that that the product (medical device) has been designed in accordance with the requirements of a medical device quality management system.

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  • Technical File documentation:

At a minimum, technical documentation for medical devices and invitro diagnostic should have:

  • A medical device description and specification section. Including medical device basic UDI.

  • Medical Device Labeling and instructions for use. 

  • Detailed information on design and manufacturing of the medical device.

  • Detailed risk management of the medical device quality system information in compliance with ISO 14971. 

  • Medical Device and Invitro Diagnostics General Safety and Performance Requirements (GSPR). 

  • Medical Device and Invitro Diagnostics Verification and validation information.

  • CERs (Clinical Evaluation Report) 

  • Post-market surveillance (PMS) information, including PMS plan, post-market clinical follow-up (PMCF) plan, and periodic safety update report (PSUR) for medical devices.

Clinical Evaluation Plan and Report (CER) generation

What is a Medical Device Clinical Evaluation Report CER?

A Medical Device Clinical Evaluation Report (CER) document establishes the conclusions of a clinical evaluation of your medical device. A CER may contain bibliographic information of substantially equivalent medical devices, as appropriate, or must contain information from clinical investigations, known as clinical trials. The data must be analyzed and the conclusions must be clear and objective to show the Clinical Evaluation of the medical device.
The medical device CER must contain the information regarding the Post Marketing Surveillance (PMS), Periodic Safety Update Report for Medical Devices (PSUR) and any relevant documents related to the medical devices.

Quality System Management
QMS -
ISO 13485

Do I need a MDR - QMS for the medical devices class I?

Being in compliance with ISO 13485 is not enough. The applicable provisions of the MDR will be integrated into the QMS of the manufacturer, of a class I device. This medical device quality system allows the correct assessment / decision to be made and the proper documented evidence to be created, ensuring compliance with the following requirements

  1. Confirm your product as a medical device

  2. Confirm product as a Class I medical device 

  3. ​Meet the general safety and performance requirements​​ for the medical device quality system

  4. Conduct clinical evaluation for the medical device

  5. Prepare technical documentation for the medical device

  6. Request Notified Body involvement, if needed

  7. Prepare Instructions for Use and Labelling for the medical device

  8. Check compliance with general obligations for medical device´s manufacturers

  9. Check compliance with general obligations for medical device´s manufacturers  

  10. Affix the CE marking on the packaging of the medical device

  11. Registration of medical devices and manufacturers in Eudamed

  12. Post Market Surveillance (PMS) 

    1. Review experience gained from Post-Market Surveillance ​Vigilance

    2. Non-conforming products

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