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Quality assurance

Our quality policy

As part of our dedication to excellence, MD Alloys is committed at all times, to the supply of high quality medical products, to innovative designs, that will provide outstanding value to our customers.

 

Our management team will strive to maintain the highest possible standards of quality and service that meet or exceed the expectations of our customers.

It is our policy to:

  • Rigorously enforce our quality management system and ensure that all of our staff are thoroughly trained and committed to the delivery of excellent customer service.

  • Strive for continual improvement in our service delivery and monitor our performance by effective communication with both our customers and our staff.

  • Develop or acquire products that are effective, safe and reliable and offer outstanding value.

  • Ensure that our quality objectives are continually reviewed and consistently achieved.

Harmonised standards

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  • ISO 13485:2016 Medical Device Quality Management System

  • MEDDEV 2.12/1 rev 8 Guidelines on a Medical Devices Vigilance System.

  • BS EN 20417:2021 Information supplied by the manufacturer of med devices

  • EN 15223-1:2021 Symbols for use in the labelling of medical devices

  • ISO 14971:2019 Application of risk management to medical devices

  • ISO 5832-4:2024 Implants for surgery metallic materials Part 4

  • ISO 5832-12:2019 Implants for surgery metallic materials Part 12

  • ISO 22674:2022 Dentistry – Metallic materials for fixed and removable restorationsand appliances

  • ISO 10271:2020 Dentistry – Corrosion test methods for metallic materials

  • EN ISO 10993-5 Biological evaluation of medical devices – tests for in vitro cytotoxicity

  • EN ISO 10993-10 Biological evaluation of medical devices – tests for irritation and skin sensitization

  • EN ISO 10993-11 Biological evaluation of medical devices – tests for systemic toxicity

  • BS EN 1641:2009 Dentistry – Medical devices for dentistry materials

  • ISO 7405:2018 Evaluation of biocompatibility of medical devices used in dentistry

Medical/bespoke QUOTE

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