Regulatory and Market Intelligence

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WELCOME TO

• Cert3Global

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Cert3Global provides medical device consulting
services and related solutions to manufacturers
and distributors of medical devices. We have
helped many companies navigate the complex world
of medical devices through our unique blend of
industry expertise and practical experience.
Whether you are looking for assistance with
internal audits or to delegate the running of
your entire quality management system, we can
support.
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• PMS is a regulatory requirement for medical
  devices in Europe. The purpose of PMS is to
  ensure that the manufacturer has taken
  appropriate steps to ensure that their products
  are safe and effective. This includes ensuring
  that the product meets the required standards, as
  well as providing adequate training and support
  to healthcare professionals using the product.

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• Medical Device Manufacturers are required to have
  a Post Market Surveillance System (PMS). In
  Articles 85 and 86, the Post Market Surveillance
  reporting requirements have been described.
  According to Article 85, Manufacturers should
  produce a Post Market Surveillance Report for all
  lower-risk (Class I) devices. PMS should be
  updated on a regular basis. It is suggested that
  the manufacturer do this at least once every
  three years.

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For More Detail

• Visit here- https//www.cert3global.com/
• Email us enquiry_at_cert3global.com
• Contact us 44 75488 25133
• Address Office 54, No58, Peregrine Road,
  Hainault, IIford, Essex, England. IG6 3SZ

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