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Technical documentation review & guidance

Regulatory writing and documentation preparation is an important part of every process whether it is QMS implementation, CE application and other submission processes. The proper documentation saves time and speeds up the process bypassing the rejections and non conformity issues.

Med devices offer its services for the following documents review and preparation guidance as per your organization needs and requirements.

  • Quality manual
  • Quality procedures
  • Instruction manual (IFU)
  • Risk analysis as per ISO 14971
  • Clinical validation Reports through literature review
  • Sample labels preparation
  • Post marketing Procedures
  • 510 K /PMN Preparation

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Testimonials

  • I would like to thank entire team of Meddevices for your assistance and guidance in obtaining ISO & CE certification. Your help will be instrumental in our continued growth & success.

    Arul Pragyasam
  • Thank you Meddevices! They have tackled all aspects of my CE case in a very short period of time. They are by far the best team I have worked with..

    Karen Roberston
  • I wouldn’t think of facing an FDA audit without Meddevices’s Assistance..

    Gerhard frick
  • I deeply appreciate the outstanding service that Meddevices have provided us over the last ten years..

    Gregony Denton

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Company Info

MED DEVICES LIFESCIENCES LIMITED was formed to provide medical device manufacturers world-wide with flexible and well adjusted service packages to assist its clients to comply with EU & US legislation .

Med Devices 123 fifth Avenue
New York, NY 10160
Ph: +19142942185
Email: info@meddevices.com
                        

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