- Medical devices are appropriately managed and controlled throughout the supply chain thus ensuring their safety and performance at the point ouf use.
- Provides assurance to stakeholders through certification that the Organization is able to maintain the quality, safety and performance of medical devices while under its custody.
- Fulfilment of establishment licensing requirements.
ISO13485 & GDPMD Certification Process:
Quality system audit services (GDPMD and ISO 13485) for establishment licensing.
Newera International Certification is qualified to conduct audits of a manufacturer’s quality management system as required by the provisions of the MDA, including Good Distribution Practice of Medical Device (GDPMD) and ISO 13485.
Product verification and CSDT file review for Medical Device Registration.