ISO 13485 – normative document developed by international attestator. The updated version was released in 2016 and became mandatory for all businesses in 2019. This act includes ensuring full openness and regulating procedures accessibility of medical equipment circulation.
Manufacturers must meet it if they want maintaining certification. To this end, it is checked whether your QMS is capable of continuously monitoring and managing equipment life cycle and related activities. Unlike ISO 9001, for example, the emphasis is not so much on continuous or continuous improvement as on product safety. Particular attention is paid to risk control. This means new standard poses challenges for medical equipment producers and for service providers.
ISO 13485 is needed and appreciated in medical market as it guarantees:
This act is designed to help companies improve their administration systems and focus on improving their own approach to risk control and compliance. It complies with ISO 9001: 2008, not 2015. This discrepancy happened because two standards revision ends in parallel, and because ISO 9001: 2015 is invalidated for equipment.
Company top members must clearly represent near plans. If intended market for medical products sale is countries of European Economic Union, then for an effective competitive advantage and the fulfillment of a number of legislative requests, it is enough to develop and certify QMS in accordance with ISO 13485 by any local by an authorized certification representative.
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