ISO 13485 Medical Devices Certification (ISO 13485 Certification for Medical Devices)

Evolving in the Medical Device field calls for a level of perception of the regulatory background and what it implies for norms and obligations. Countries are more and more developing their local policy based on the International Medical Device Regulator’s Forum for ISO 13485 Medical Devices Certification.

Already-existing regulatory schemes tend to be evaluated by Health Authorities controls and/or Certification Bodies. The preponderance of these regulations has a common base the Quality Management System (QMS) and Risk management principles. ISO 13485, in its fresh evolution, corroborates that the regulatory necessities are meant to be a key deliberation in the future of Quality Management Systems.

ISO 13485 Medical Devices is a globally recognized standard for establishments involved in the medical device industry. Firms are using compliance to this standard to obtain the certification of their Quality Management System. The most important reason for the ISO 13485 Certification is the Harmonization of the Medical Device regulatory requirements for Quality Management Systems.

The ISO 13485 certification is a proof of Quality Management System compliance with the standard for establishments involved in the Medical Device industry. This approach is not only followed by Medical Device Manufacturers but also supporting establishments such as Subcontractors, Suppliers, European Authorized Representatives, specialized Consulting firms etc…

Note that ISO 13485:2016 expands the profile of firms and establishments to which the standard can apply:  Establishments involved in one or several stages of a Medical Device Lifecycle or a Supplier or other External Parties providing such establishments with products for example.

ISO 13485 QMS stresses on the harmonization of the Quality Management Systems in the framework of Medical Device regulatory requirements. It is not astonishing to see that many authorities be familiar with or even necessitate that Medical Device makers attain ISO 13485 certification in order to access their market.

Many regulatory authorities have accepted the ISO 13485 certification standard as an element of their own requirements to enable the sale of Medical Devices on their region. The Medical Device solitary review Program went a step further: it is built on the ISO 13485 principles and comprises those values as part of the audit criteria.

Of your own accord compliant to ISO 13485 is the best tactic that firms have to get ready for a global market access. Having ISO 13485 Certification offers business partners and owners with the poise that the establishment has put all the efforts to be conventional to the standard.