The Certifications

CE marking

MEDALKAN products are CE marked

CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.

MEDALKAN products are CE marked in accordance with Directive 93/42/EEC and the MDR Regulation* (Council Regulation 2017/745/EU) for medical devices.

Since May the 26th. 2021, all medical devices commercialised in Europe must be in conformity with the regulation for medical devices MDR (EU) 2017/745.

MEDALKAN ISO CE

These new provisions should ensure increased patient safety in all countries of the European Union. In addition, medical devices must meet these stringent requirements in order to be eligible for market authorisation and guaranteed availability for the patient.

MEDALKAN complies with the requirements of the new Regulation MDR (EU) 2017/745.

ISO 9001 and ISO 13485

MEDALKAN is certified ISO 9001:2015 and ISO 13485:2016

ISO 9001:2015 is the standard that provides all the requirements for a system of quality management.

Thus our company responds point by point to general requirements concerning:

  • Design
  • Development
  • Manufacturing
  • Storage
  • Marketing
Certifications

ISO 13485:2016 certification specifies requirements for the system of quality management when a company (company developing medical products, clinic, hospital, etc …) needs to demonstrate its ability to provide medical devices and related services regularly and compliant to the requirements of the customers and the regulatory requirements relevant to medical devices and related services.

Thus, Medalkan meets the particular requirements for medical devices such as:

  • Compliance with regulatory requirements;
  • The control of special processes;
  • The risk analysis throughout the product development;
  • Clinical trials and the long-term monitoring of these trials;
  • Traceability of products from conception to commercialization

This certification is a proof of commitment from Medalkan concerning the quality of its products and enables it to demonstrate that its system of quality management has been assessed and found compliant with regulatory requirements and customer needs.

Good Manufacturing Practice (GMP)

MEDALKAN applies Good Manufacturing Practices (GMP) which guarantee the uniform manufacture and control of products and thus ensure quality.

GMP covers all aspects of production and control processes:

  • A determined manufacturing process and validated critical steps
  • Suitable premises, storage and transport
  • Trained and qualified production and quality control personnel
  • Sufficient and qualified facilities
  • Approved written instructions and procedures
  • Complete traceability of a product thanks to batch records
  • Systems for registration and examination of claims
  • An internal audit system for the verification of the implementation and       monitoring of GMP
    • MEDALKAN ISO CE