ISO 13485:2016 / MDSAP

  • Gap analysis
  • Audit preparation
  • Audits (13485:2016 / MDSAP)
IRCA/CQI certified lead-auditor for ISO 13485:2016/MDSAP

Since May 2021, there are new European rules for medical devices (MDR). Manufacturers, importers and distributors of medical devices will have to deal with the rules. The new regulations are far-reaching, because the definition of a medical device has changed. For example, medical software that was not previously covered by the Medical Devices Act (MDD) can now be a medical device under the MDR.

ISO 13485:2016 introduces a host of subtle – but detailed – changes that involve more thorough documentation on work environment, risk management, design review and regulatory requirements. The standard includes the need for a risk-based approach to the QMS and a better focus on top management responsibilities. More control over suppliers and outsourced activities and more emphasis on risk management throughout the product lifecycle are also enforced by the standard. The new rules therefore have consequences for the entire chain: healthcare institutions, healthcare providers, system developers and (indirectly) for patients.

Opportunities through frameworks

 The new standard provides medical device manufacturers – and organisations that support those manufacturers – with an excellent framework for setting up the quality management system to ensure compliance with the European Medical Device Regulation (MDR/EU 2017-745). ISO 13485 is an international standard, has the basis in ISO 9001 and has been specially developed to help manufacturers of medical devices comply with European legislation. In 2016, the standard was updated – partly due to technological and medical developments – and linked to the MDR.

Bring out the Best is happy to support you in achieving or maintaining an ISO 13485 certificate, refining the product development lifecycle to ensure timely market introduction. With the interest of the patient as a priority.

Medical Device Single Audit Program (MDSAP)

 The International Medical Device Regulators Forum (IMDRF) has a working group

established to develop a standard set of requirements for audit entities (certification bodies) that conduct regulatory audits of the quality management systems of medical device manufacturers. The program requirements of the Medical Device Single Audit Program (MDSAP) apply to regulatory agencies and external organizations that conduct the audits.

The goal of the MDSAP is to develop and manage a single audit program that allows a single regulatory audit of a medical device manufacturer, performed by an MDSAP-recognized audit firm, to be performed to meet the needs of multiple regulatory jurisdictions. In this way, more coherence is achieved. The basis for the MDSAP remains ISO 13485:2016.

Bring out the Best can use this program for a gap assessment, an internal or a supplier audit. And therefore offers the most up-to-date working method, with which you can continue.