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Medical Device Single Audit Program (MDSAP) Certification

A single scheme to demonstrate compliance.

The Medical Device Single Audit Program - more commonly known as MDSAP - allows medical device manufacturers to demonstrate their compliance to the regulatory and quality management system requirements of multiple jurisdictions through one audit scheme.

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Overview

The Medical Device Single Audit Program (MDSAP) was introduced in 2014 as a pilot scheme and by 2016 was in its full form. This single scheme covers the regulatory and quality system requirements of the multiple MDSAP jurisdictions.

The approach is led by the Regulatory Authorities (RAs) of the MDSAP jurisdictions and is designed to improve the medical device approval process by:

  • Boosting efficiency - offering manufacturers a single audit to fulfil the needs of 5 current jurisdictions.
  • Increasing safety - sharing information internationally.
  • Facilitating technology transfer between markets - offering a consistent format for audits and their reports to allow manufacturers to better manage their market authorisations.
  • Bring together different stakeholders to ensure a wide-reaching, deep thinking approach that will sustainably shape the medical device industry into the future.

MDSAP is not a market authorisation for the MDSAP jurisdictions.

MDSAP is not ISO 13485 certification, but the audit model is based on ISO 13485 and therefore a combined audit delivered by the same Auditing Organisation can save additional costs compared to separate audits.

What we offer

The MDSAP audits are conducted by Auditing Organisations (AOs). AOs are authorised by the MDSAP RAs to audit under the MDSAP requirements following a prescriptive audit model that includes risk-based links that run through the quality management system and the regulatory requirements.

LR joined the MDSAP scheme in 2015 and has been growing in strength since then. LR offers an agile and flexible response to your MDSAP certification requirements, providing a thorough and high-quality audit service that will allow you to mitigate risks.

What are the benefits

Single audit, multiple benefits.

A single audit is used in place of multiple separate audits or inspections by participating RAs. Therefore, for medical device manufacturers, the MDSAP reduces the number of audits or inspections required, optimising the time and resource expended on audit activities.

Increased transparency and operational efficiency.

Through standardising the practices and procedures of participating regulators, medical device manufacturers can benefit from more consistent, predictable and transparent regulatory programs. In addition, manufacturers may gain the ability to expedite entrance to some markets where traditional regulatory oversight can cause significant inspection and audit delays.

Over time it is expected that more regulatory authorities will join the program and that it will enhance confidence in the reliability of third-party audits.

Why choose LR?

Why work with us?

With more than 20 years’ experience, our assessors are industry specialists and experts, enabling an effective and robust assessment of your system. Leading and emerging medical device manufacturers around the world choose LR because we are globally recognised and accredited whilst offering:

  • Impartiality and objectivity
  • A well-refined assessment methodology
  • An agile response to meet your business needs

How we can help

We apply our expert solutions and independence to assure the integrity, reliability and success of every aspect of your operation. Helping maximize productivity and recovery, reduce operating costs, mitigate risk and demonstrate compliance with government regulations, industry codes and standards, many of which we have helped to develop.

INSIGHTS

What we think

LR's experts regularly share their research and insights.

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