Patient health is of paramount importance in the medical device industry, which is why it’s a highly regulated industry. Medical device manufacturers must adhere to the compliance of regulatory agencies in order to ensure product safety and quality. The MDSAP audit enhances transparency and consistency in regulatory inspections by using standardized procedures and trained auditing organizations. This uniformity minimizes the risk of varying interpretations between different regulatory bodies, thereby reducing uncertainty for manufacturers.
In addition, if medical device manufacturers want to market their products in multiple countries, then they need to comply with the regulatory agencies of various countries. Ensuring compliance in multiple markets can be laborious and complex. The MDSAP audit reduces multiple, overlapping inspections. As a result, medical device manufacturers can allocate their resources more efficiently.
The MDSAP Audit Program streamlines and simplifies compliance. It enables medical device manufacturers to hire an auditing organization for the annual evaluations of their QMS. In this article, we discuss the MDSAP audit, its advantages, the assessment program, and the process in detail.
What is MDSAP?
MDSAP, abbreviated for Medical Device Single Audit Program, is a standard set of requirements for auditing organizations or certification bodies that perform regulatory audits of medical device manufacturers’ QMS, abbreviated as Quality Management System.
The MDSAP Audit was initiated by the International Medical Device Regulators Forum, abbreviated as IMDRF. It was developed to include the regulatory requirements of ISO 13485:2016.
MDSAP Audit Advantages
Clear Process
The MDSAP program outlines a step-by-step process that enables QMS customization to the specific requirements of MDSAP. It’s an extremely clear process to follow that eliminates discrepancies.
Reduced Audits
Typically, a medical device manufacturer is required to demonstrate consistent compliance with the QMS requirements of each regulatory agency. MDSAP significantly reduces the number of audits from various regulatory bodies.
Time Efficiency
MDSAP consolidates various audits into one audit. Thus, reducing the number of audits and inspections and thereby increasing time efficiency.
Cost Reduction
In addition to saving time, the MDSAP audit also reduces costs. You should note that conducting a single audit is more cost-effective than conducting multiple audits.
Prioritized Nonconformity Findings
The non-conformity findings are graded by severity, which further enables medical device manufacturers to prioritize the non-conformity findings. Thus, enabling efficient rectification of errors.
Accelerates Acceptance in Multiple Markets
MDSAP audit reports are accepted among participating countries. Thus, MDSAP accelerates the acceptance of medical devices for manufacturers across multiple markets.
MDSAP Participation
MDSAP has active participation from various countries, and they include specific market requirements within the framework of the MDSAP audit.
Medical device manufacturers must specify the marketing countries when they plan to undergo the Medical Device Single Audit Program. The on-site audit further evaluates the medical device manufacturer’s QMS against the regulations of the listed countries.
United States of America – FDA
The U.S. FDA accepts MDSAP audit reports. You should note that initial visits and routine inspections that are conducted “For Cause” or “Compliance Follow-up” will still be conducted and aren’t affected by MDSAP audits.
Canada – Health Canada
Health Canada recognizes the MDSAP as a QMS requirement of the CMDR. Since 1st January 2019, Health Canada has only accepted MDSAP audits and mandates the requirement of the MDSAP certification for Class II, III, or IV medical devices.
Australia – TGA
Australia’s TGA, abbreviated for the Therapeutics Goods Administration, recognizes clearing the MDSAP audit as a satisfactory QMS requirement. You should note that the MDSAP certificates are equivalent to CE certificates of the European Union, as per the TGA.
Brazil – ANVISA
Brazil’s ANVISA accepts MDSAP audit reports. It utilizes the MDSAP audit report in its certification decision and for initial audits. It, however, conducts its inspections for higher-risk devices.
Japan – MHLW & PMDA
Japan accepts the MDSAP audit results, and when the report is submitted, MHLW and PMDA utilize the MDSAP report.
MHLW refers to the Ministry of Health, Labour and Welfare, and PMDA refers to the Pharmaceuticals and Medical Devices Agency.
MDSAP Audit Process Details
MDSAP Audit Process Elements
There are seven MDSAP audit process elements. Let’s understand these process elements further:
Management
The very first process in the MDSAP audit sequence is the management process. The main aim of auditing the management process is to verify if the top management develops and maintains an effective quality management system.
The management process provides resources from device design and manufacturing to quality assurance, servicing activities, and more. The main aim here is to monitor the QMS and ensure that it is working correctly.
Device Marketing Authorization and Facility Registration
The next process that is audited is the device marketing authorization and facility registration. The main aim here is to ensure that the medical device organisation has performed all the activities that are required for device marketing authorization and facility registration with regulatory authorities participating in the MDSAP audit.
Measurement, Analysis, and Improvement
The purpose of auditing this process is to identify any type of cause or concern in the product, process, and/or the QMS. These causes or concerns must be identified so that either corrective or preventive actions can be taken.
Medical Device Adverse Events and Advisory Notices Reporting
The auditing of this process verifies that the adverse events and advisory notices of the individual medical devices are relayed by the medical device manufacturers’ processes to the regulatory authorities in a timely manner.
Design and Development
The next MDSAP audit process element is the design and development process. The main aim of auditing this process is to control the design and development of a medical device to ensure that it meets all the specified requirements and its intended use.
Production and Service Controls
The purpose of auditing this process is to verify the process capability of ensuring that the products meet the required specifications.
Purchasing
The intent of auditing this process is to verify that the products or services are as per the specified purchase requirements.
You can read more about the key process elements here.
MDSAP Audit Assessment Program
The MDSAP audit includes an initial assessment, two surveillance assessments, and a final re-recognition assessment. The following infographic indicates the 3 types of assessment of the MDSAP audit:
Initial Assessment
Stage 1
Stage 1 of the initial assessment is the assessment stage that includes the documentation review. In this stage, the documents are reviewed thoroughly to determine the preparedness of either the head office or any other location for an on-site assessment.
Stage 2
If the documentation and overall preparedness are satisfactory, then an on-site audit is conducted to evaluate the QMS compliance. This is a thorough on-site assessment.
Surveillance Audits or Assessments
Surveillance audits are conducted annually. They assess if any changes were made to the QMS or the products since the completion of the initial assessment. Typically, two surveillance audits are conducted. They are conducted in the first and second years. After the second audit is completed, the notified body reviews any findings observed during the prior audits.
Recertification Assessment
A recertification assessment evaluates a manufacturer’s QMS to ascertain its continued suitability and effectiveness in meeting QMS requirements under MDSAP. You can read about the MDSAP audit approach in detail here.
MDSAP’s Nonconformity Grading System
MDSAP’s nonconformity grading system includes two steps. Let’s understand these steps in further detail:
Step One: The Grading Matrix
In step one, the grading matrix is incorporated. The points are assigned to non-conformities that indicate the requirements that aren’t met in ISO 13485:2016. The grading matrix is a 4-point grading matrix and is depicted in the infographic below:
The point grade system is from 1 to 4, but it can expand to additional points under certain scenarios. It’s based on two aspects – the occurrence of nonconformity, i.e., either first or repeat, and the impact on QMS, i.e., either direct or indirect QMS impact.
Let’s understand these factors further:
QMS Impact
- Indirect QMS Impact: These types of impact specifically refer to nonconformities that influence ISO 13485:2016 clauses, which further impact the safety and performance of medical devices indirectly.
- Direct QMS Impact: A direct QMS impact occurs when the nonconformities directly impact the design and manufacturing controls, thereby impacting the safety and performance of medical devices.
Occurrence
- First Occurrence: A nonconformity in a particular sub-clause of ISO 13485:2016 is referred to as “first occurrence” when the nonconformity is observed for the first time. To clarify further, if the same nonconformity isn’t observed in the previous two QMS audits that evaluated the same sub-clause, it is referred to as “first occurrence.”
- Repeat Occurrence: A nonconformity in a particular sub-clause of ISO 13485:2016 is referred to as a “repeat occurrence” if the nonconformity was identified in the previous QMS audits as well. You should note that it should have evaluated the same sub-clause. A repeat occurrence indicates that corrective action hasn’t been implemented correctly, which is why it poses a higher risk.
You can read more about the Nonconformity Grading System for Medical Devices here.
Step Two: Grading Escalation Rules
This step involves the escalation process of the nonconformity grading system to indicate and address high risks. These higher risks indicate that the medical device safety and performance are impacted to a larger extent.
Rules for Grading Escalation
The grade that is determined through step one, i.e., the grading matrix, can be escalated to be increased by 1 point for each rule. These rules are applied for the following conditions:
- During the absence of a documented process or procedure.
- During the release of a nonconforming medical device.
Nonconformity Grades 5 and Above
A grade of 5 or above denotes that the risks are larger. It indicates that an intervention is required.
The grades are recorded on a standardized audit information form, through which the audit information is exchanged between various regulatory bodies.
MDSAP Medical Device Manufacturing with VEM Thailand
Medical Device Single Audit Program enables medical device manufacturers to comply with the regulatory agencies of multiple markets. We can help you learn more about MDSAP auditing and other solutions as well.
VEM-Tooling and VEM-Medical have a team of expert engineers with over 20 years of experience in manufacturing high-quality medical device plastic parts. We have been strictly applying QMS for our OEMs in the medical device industry. You can view our certificates here.
