GDPMD is a regulatory requirement that affects parties involved in the distribution of medical devices, from manufacturers, wholesalers, importers and exporters as well as distributors, regardless of business size. GDPMD specifies the requirements for a quality system to be established and maintained effectively to maintain safety and performance of medical devices throughout the supply-chain. This is an audited system that affects the organisation license to operate.

GDPMD also aims to provide a clear legal framework which identifies responsibilities and accountability of all stakeholders throughout the supply chain. As part of the regulatory requirements, stakeholders need to have the appropriate procedures, personnel, processes, facilities, equipment and documentation in place.

Why Mindsky ISO Consultant

  1. We empower the intelligence of our customer MINDs to reach the SKY level of freedom to perform better.
  2. We care our customer utmost satisfaction.
  3. We do not compromise on quality delivery.
  4. We give our honest feedback to our customers.
  5. We deliver solutions to meet our evolving customer needs.
  6. 100% success rate for GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES (GDPMD) Certification.

Industry Cover

Our client industry chart %: Distributor 87%, Manufacture 13%.

We coach, we teach, we guide, we share and we empower all our clients with our real experience to gain their freedom to perform better.

At MindSky, we try our best to connect you with the most appropriate person for your needs.

Mindsky ISO Consultant is experienced and provided few useful suggestion for our organization to improve the ISO documentation and procedure. we really like the way Consultant did the consultation. Also she has helped us to developed some department SOPs for us.

ISO 9001 testimonial client
Jared Chen
Top Management, Hi-Tech Recond Auto Part Sdn Bhd

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