Medtechtomarket Ltd Achieves ISO 13485 Recertification
Medtechtomarket Ltd Achieves ISO 13485 Recertification
Medtechtomarket Ltd Achieves ISO 13485 Recertification
Medtechtomarket has once again achieved ISO 13485:2016 certification. ISO 13485 is the standard for a Quality Management System (QMS) for the design and manufacture of medical devices. Certification to the standard requires an organisation’s quality management system to pass a third-party Medical Device Single Audit Program, or “MDSAP” Audit.
The scope of our ISO13485 certification includes: Design, Development and Manufacture of in vitro diagnostic medical devices, including cartridges, controls, analyzers, software and accessories used in the diagnosis and management of disease status. Provision of contract design and development, validation, manufacturing, clinical studies, regulatory support and launch activities for IVD and Medical Device technologies. Read more about our process HERE
By aligning our quality management system with ISO 13485, Medtechtomarket can reduce the risk of product nonconformities and ensure patient safety. Additional benefits include:
- Ability to minimize errors, waste, and rework, resulting in increased efficiency and cost savings
- Consistency of products and services through increased traceability
- Insight into process and product performance through ongoing monitoring and data analysis
- Easier certification process for other regulations such as FDA and EU MDR
- Opportunity to enter new markets and expand customer base
- Increased customer satisfaction
- Strengthened brand reputation
The full title of the standard is “ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes.”
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The MedtechtoMarket team has worked together directly for over 25 years developing, producing and launching products in over 50 countries worldwide.