The Medical Device Single Audit Program (MDSAP) is designed to streamline the auditing process for medical device manufacturers operating across multiple jurisdictions. Based on ISO 13485, MDSAP incorporates additional regulatory requirements specific to the participating countries: United States, Canada, Australia, Brazil, and Japan. Whilst MDSAP is optional in most participating countries, it is mandatory in Canada. It is also worth noting that Europe, Singapore, and the UK are official observers of MDSAP, with aspirations for the UK to become a full participant and many other jurisdictions are affiliate members, benefiting from access to key information on medical device safety.
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What is the MDSAP Audit Approach?
MDSAP enables a single regulatory audit to be recognized by all participating countries, significantly reducing audit duplication and overall costs. The unified approach saves time and resources, and also drives the harmonization of compliance standards across different jurisdictions. The MDSAP Audit Approach document outlines the criteria and elements MDSAP auditors will assess during the audit process, providing transparency on the audit process and a clear pathway for compliance.
Supplier Management Under MDSAP: Key Considerations for Medical Device Manufacturers
For medical device manufacturers aiming for MDSAP compliance, supplier management is a critical focus area. Often it is an afterthought as the manufacturers prepares for certification, when it should be incorporated into design and development of the medical device. Chapter 7 of the MDSAP Audit Approach highlights five key outcomes that auditors normally expect from manufacturers:
- Defined, Documented and Implemented Procedures: Manufacturers must establish clear procedures to ensure all specified purchasing requirements are consistently met.
- Supplier Selection and Evaluation Criteria: Key criteria must be established for selecting and evaluating suppliers. This evaluation should consider the significance of the purchased product and its impact on subsequent products or finished devices.
- Evaluation Based on Specified Requirements: Supplier evaluations should be based on the ability of the supplier to meet predefined specifications and requirements.
- Ongoing Supplier Re-Evaluation: Regular re-evaluation of suppliers is necessary to ensure ongoing capability to deliver quality products. The scope, depth and frequency of re-evaluations should be defined by the medical device manufacturer based on risk.
- Control Measures and Verification Activities: Implementing an appropriate combination of control measures on the supplier and acceptance verification activities on the purchased product is essential to ensure safety and performance of the finished medical device.
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The MDSAP Audit Approach serves as a practical guide combining the ISO 13485 requirements with regulatory requirements for supplier management. There some harmonization across the requirements of the participating countries and an overall shared vision, making compliance less daunting for manufacturers operating on a global scale.
How MDSAP develops the concepts of ISO 13485 related to supplier management
MDSAP builds on the foundation of ISO 13485 by incorporating all of its requirements and then adding more requirements. Some are general and applied to all MDSAP audits; others are specific for a participating jurisdiction and only applicable when the manufacturer is placing products on that market.
Examples include:
1. Purchasing Criteria:
ISO 13485 Clause 7.4.1 states the manufacturer should establish procedures to ensure that the purchase products meet their requirements. This includes:
a. Evaluating the supplier’s ability to deliver the correct products
b. Assessing supplier performance
c. Considering the impact of the supplied products on the medical device.
The measures and actions should be proportional to the associated risk and include ongoing monitoring and re-evaluation, taking into account the supplier’s performance in meeting these requirements.
The MDSAP Auditing Approach Chapter 7, Tasks 1-7 (as well as Chapter 3, Task 13) build on these requirements adding, for example, linking purchasing into design and development considerations.
2. Specified Agreements:
ISO 13485 Clause 7.4.2 describes the purchasing information and states the manufacturer decides when it is applicable to establish written agreements with supplier to ensure notification of change to the product. The MDSAP approach is more stringent with the MDSAP Auditing Approach Chapter 7, Task 8 requiring that the auditor confirms that a written agreement is established.
3. Evaluation & Re-evaluation:
ISO 13485 Clause 7.4.3 states the manufacturer shall establish and implement activities, including inspections, to ensure that the purchased product meets requirements. These activities should be proportionate to risk and consider how to manage changes. This information feeds into the evaluation and re-evaluation of the supplier, detailed in Clause 7.4.1.
The MDSAP Auditing Approach Chapter 7, Tasks 1 and 10 links purchasing to production controls, considering how the criteria established for supplier (re-)evaluation and acceptance of the purchased product impact the quality of the medical device on an on-going basis.
Conclusion
Supplier evaluation is crucial for ensuring the quality, safety, and compliance of medical devices. It helps manufacturers select suppliers that can consistently meet specified requirements, minimizing the risk of defective or non-compliant components that could compromise the performance of the final product. Regular evaluation and re-evaluation of suppliers also enable manufacturers to proactively identify and address issues, maintain high standards throughout the supply chain, and ensure that suppliers adhere to regulatory and quality management standards.
ISO 13485 provides a framework for supplier validation which is further developed under MDSAP to meet the regulatory requirements of different countries, providing manufacturers with a holistic approach to supplier validation. Ultimately, effective supplier evaluation, supported by MDSAP, safeguards the integrity of medical devices, supports regulatory compliance, and protects patient safety.
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