MDSAP – A boon or not

 

MDSAP: An Introduction

MDSAP or Medical Device Regulators Forum Single Audit Program is aimed at reducing the quality overhead faced by medical device manufacturers owing to multiple regulatory and other audits that often may seem redundant as they are each assessing the same requirements including that of ISO 13485 training of personnel. The intent of MDSAP is to serve as a single audit program that will then be accepted by multiple countries. Until date only a few countries have signed onto the program.

The Single Audit program aims to speed up the process by which markets can gain access to medical devices and associated services as well as to reduce the overhead costs for manufacturers. The program also aims to streamline the interpretation of various requirements. Just as with ISO 13485 training where auditors learn a common interpretation of the standard so it is uniformly applied globally, similarly MDSAP approved auditors will be trained so that audit conclusions will be reliable and reproducible.

Regulations such as FDA’s 21 CFR and EU MDR require nearly the same requirements as does a management system aligned to ISO 13485. Often each standard/regulation then gets audited separately. This can prove costly for all parties concerned and in the long run does not provide any added value. Statistics claim that MDSAP will reduce audit time by up to 20% for small firms. The program will also lead to a singular database of manufacturers globally and so when one regulator identifies an issue this will not be missed by other countries/regulators and oversight bodies. MDSAP looks to implement a free information exchange between participating organizations. The program sees this as a benefit to patient safety from the increased transparency.

MDSAP requirements are primarily based on ISO 13485 and ISO 13485 training will be helpful especially if auditors are looking to be certified to do both types of audits. In addition will be the requirement of participating countries. MDSAP audits are done by process areas. There are four primary processes or process groups: management; measurement, analysis and evaluation; Design and development; Productions and service controls. There are also three supporting processes: Purchasing; Device Marketing Authorization and Facility Registration; Medical Device Adverse Events and Advisory Notices Reporting.

ISO 13485training will prepare auditor to audit ISO 13485 quality management systems. The standard when revised in 2016 did not adopt the high-level structure of ISO 9001. In addition to this training auditors will also need to have knowledge of the MDSAP program and relevant regulations as applicable. MDSAP will prove to be beneficial to all concerned provided unity in implementation of the program among countries prevails.