Novosys Pte Ltd, Singapore (Novosys)

SS 620:2016 – Good Distribution Practices for Medical Devices (GDPMDS)

GDPMDS Singapore

GDPMDS Singapore

GDPMDS Singapore: Good Distribution Practice (GDP) is that part of quality assurance which ensures that wholesalers or importers possess the necessary quality management systems, procedures and facilities to handle medical devices, ensuring that that products are consistently stored, transported and handled under suitable conditions as required by the marketing authorization or product specification.
Who needs GDPMDS?

  • Organisations that are involved in wholesaling and/or importing Medical Devices in Singapore it is a mandatory requirement to pass the GDPMDS certification audit prior to applying for Importer or Wholesaler’s License.
  • Medical devices companies are required to implement quality management systems, procedures and facilities to handle the medical devices in accordance with current Good Manufacturing or Distribution Practice of Medical Devices.

Implementation of Good Distribution Practice for Medical Devices GDPMDS Standard:
Our expert consultants team will ensure a smooth implementation of GDPMDS Standard by providing an implementation plan and ensuring the implementation is complete in a timely and result-oriented way. Contact us to know more information.

Competitive Advantages of SS 620:2016

Having a well- designed Good Distribution Practice for Medical Devices GDPMDS will give organisation, consistent product or service quality, efficiency and cost benefits. organisation will also get the Importer or Wholesaler’s License in Singapore after obtaining GDPMDS certification.

Process Flow

Initial
Consultation

Our consultant will contact you to gather information about your organization to understand your company needs and ISO standard requirements.

Gap Analysis and Planning

Assess your organization’s current practices and identify gaps. Develop a plan to address the gaps and achieve ISO compliance.

Documentation and Implementation

Develop necessary documentation, policies, and procedures. Implement the changes and new processes within your organization.

Training and Awareness

Provide training to employees on ISO standard requirements and their roles in the implementation.

Internal Audits

Conduct internal audits to assess the effectiveness of the implemented ISO management system and identify areas for improvement.

Certification Audit and Issuance

Receive the ISO certification, upon successful audit from an accredited certification body.

Consultancy

Contact us to know more information about this consultancy service:

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