MDSAP
Medical Device Compliance and How to Navigate MDSAP
Mar 19, 2025
10
min read
Before MDSAP (the FDA compliance program), medical device manufacturers faced complex country-specific regulations, requiring substantial resources to meet regulatory compliance or become hindered to global market access.
Compliance automation powered by Tiebreaker A in the context of device regulation can determine compliance outcomes. It continues to deliver exceptional value by streamlining the preparation and long-term sustainability for medical device manufacturing mandated to comply with the MDSAP audit process.
What is MDSAP?
MDSAP streamlines global medical device compliance by offering a unified regulatory framework based on international standards. This unification process enables manufacturers to meet regulatory demands and ensure their device safety. With MDSAP, this compliance process saves time and resources compared to individual assessments, allowing manufacturers to concentrate on developing innovative devices.
Medical device manufacturers are required under MDSAP to enable a quality management system (QMS) to support compliance governance processes. These processes include:
Organization management accountability and responsibility
Resource management supporting all medical device manufacturing processes
Product design realization or lifecycle management for each medical device must adhere to 21 CFR Part 820.
Defining the measurement point-system for MDSAP compliance
Defining and executing a continuous improvement workflow.
Managing and monitoring production and service controls
Purchasing
Medical device manufacturers leveraging MDSAP also see cost reduction regarding ongoing compliance governance through automation and the reduction of human error.
Who Conducts the MDSAP Audits?
Auditing organizations (AO) plan, conduct, and report the audit to the regulatory authorities.
An AO conducts the audits as a three-year cycle. The initial audit comprises the necessary elements for ensuring medical device compliance stages.
Stage 1 - Documentation and preparedness audit (Ideal place for automation)
Stage 2 - This stage focuses on the Implementation. The AO will execute two surveillance audits and a re-certification audit in the third year.
The Role of Compliance Automation in MDSAP
Compliance automation and the importance of this functionality continue to make headway within the medical device manufacturing community. Medical device companies align their internal and external resources to look for ways to resolve the need to comply to the MDSAP compliance mandate.
Compliance automation can help ensure medical device companies meet regulatory standards. It assists in several key areas for optimizing MDSAP compliance management, including:
Staying Compliant with MDSAP
Remaining compliant with MDSAP ensures that your medical devices meet the rigorous standards required by multiple regulatory authorities. By aligning with MDSAP, manufacturers can streamline audits, reduce duplication, expedite premarket approval and boost global market access while maintaining high levels of safety and quality. Consistent adherence to MDSAP requirements is key to staying competitive in the international medical device industry.
Increasing Efficiency Regarding Data Collection for the MDSAP Compliance Audits
Timely, accessible data is vital for effective regulatory reporting. Automation keeps this data organized and ready for audits.
Improving Accuracy of the Data Collection and Reporting Requirements for MDSAP
Automated systems reduce human error, ensuring that compliance, safety and effectiveness data and reporting are more accurate and reliable methods for ensuring compliance with medical device regulations.
Reducing Compliance Operations Costs
Regulatory teams can use compliance automation for efficiency, cost avoidance, and risk mitigation. Poor audit and compliance management may cause costly mistakes—like missed compliance audit deadlines - that delay compliance mandate certifications, reduce revenue, and invite regulatory penalties.
Streamlining Audit Preparations
Before compliance automation, auditing preparation was very manual intensive and prone to human error. Organizations trying to meet various compliance mandates, including MDSAP and other FDA regulations, either failed to meet or applied for endless extensions until all the data, questionnaires, and documentation became updated.
Document management, real-time monitoring, performing gap analysis, and automating manual compliance collection workflows became quick victories for compliance automation.
Organizations should leverage compliance automation tools like Tiebreaker AI for other critical mandates, including ISO 27001 and SOC2.
By investing in compliance automation across all mandates, organizations can learn from streamlining successes and what can transcend other mandates.
Improving Documentation Review
Automating compliance policy document review is critical for all organizations, especially for MDSAP. Tiebreaker AI runs automated policy reviews, consolidates documents and provides customized recommendations to help meet updated compliance requirements. The platform helps execute policy reviews within 5 to 10 minutes. This execution process helps eliminate the manual review process that could take days, streamlining compliance for medical device companies.
Like other compliance mandates, the various governing bodies behind MDSAP also frequently change, and these changes have been published on multiple websites. Compliance tools like Tiebreaker AI help collect changes to compliance mandates from public sources and streamline updating the organization's supporting policies and documentation. The automated process alone reduces manual tasks and human errors.
One of the most time-consuming aspects of regulatory affairs is document management. AI-powered systems can now enhance the efficiency of the manual review process that could take days for device regulation. Here is what Tiebreaker AI is capable of:
Streamlining document and policy review for safety and efficacy
Supporting multiple contributors of different access levels
Preventing data sharing with third-party vendors
Identifying inconsistencies within the current policy documents and potential compliance issues
Streamlining compliance processes for MDSAP will help medical device manufacturers if they to choose to adopt the ISO 13485 framework.
What is ISO 13485 Compliance?
ISO 13485 establishes a standard for quality management systems (QMS).
Manufacturers of medical devices must develop and maintain a QMS system as a key component of the MDSAP certification process, but they must navigate complex regulatory requirements and standards to guarantee their product safety.
ISO 13485 has become a broader framework for medical device manufacturers mandated to meet other compliance frameworks, including 21 CFR 820 and ISO 9001.
Fact: It is known that life science supply chain suppliers refuse to buy medical devices that do not have ISO 13485 certification.
Like MDSAP, ISO 13485 has similar pillars embedded within its framework:
Enablement of a medical device quality management platform or QMS
Executive management responsibility of the regulatory strategy, accountability for potential issues, and providing funding for continuous compliance efforts.
Safe and effective management of resources, including materials and personnel
The cost of achieving ISO 13485 becomes a deciding factor for medical device organizations.
ISO 13485 certification costs vary based on your organization's size, complexity, and product offerings.
The estimate for an ISO 13485 audit starts at a minimum cost of $20,000, including an annual certification fee of $3,000-$5,000, audit costs of about $3,000 a day, and additional expenses for planning, reporting, and internal preparation work.
Implementing compliance automation helps lower this compliance cost even further.
Integrating Automation into Existing Workflows
Organizations looking to streamline existing workflows with automation must set the proper expectations. Automating a poorly designed and executed manual process hardly improves it with automation.
Redesigning workflows to leverage automation is a critical first step in recognizing the benefits of this capability. Automation benefits well-executed yet time-consuming manual processes, including policy documentation updates, gap analysis, and correlating questionnaires.
Several manual processes that immediately benefit from automation include the following:
Pre-populate forms with existing data from previous audit process
Generate standardized documents to ease administrative burdens
Perform quality checks to ensure compliance with submission requirements
Measuring the Success of Compliance Automation
Compliance automation, like any advanced capability incorporating rules, policies, and now artificial intelligence, requires a measurement of success layer.
Automation processes can and will fail. This failure could occur at the function's inception or after a significant update to a critical system through an automation workflow. Here are some measurements all organizations should implement to govern their various compliance automation functions.
Time Efficiency
Is the automation capability saving time? Did the automation functions execute in less time than previous manual procedures? Did the automation replace 100% of the last manual functions?
Error Reduction
Successful automation reduces or eliminates human error in pre- and post-audit compliance functions. Did the automation workflow create more errors than previous manual efforts?
Productivity Increase
Are employees becoming more productive with more compliance-related strategy workloads compared to having to execute previous manual procedures?
ROI
ROI are very challenging to calculate. Did the organization reorganize human capital and shift resources to other departments because of a successful automation deployment? Did the automation of the comprehensive gap analysis process save time and money?
User Acceptance and Satisfaction
Does the user community, compliance team, and risk management feel better about their roles with automation replacing a great deal of manual processes?
Compliance
Did the organization reduce its compliance operations costs and costs to external auditing prep firms, and did it streamline several complication mandates into a simplified process?
Automation with oversight helps organizations achieve their operational and compliance goals by optimizing their audit procedures, automating critical actions, and helping deliver an automated standardized audit process.
Why Tiebreaker AI?
Achieving success with compliance automation begins with integrating and leveraging with a proven platform. The more complex the compliance automation platform, the less likely organizations will realize their expected gains in product, cost reduction, and greater efficiencies.
Tiebreaker AI continues to set the bar in the compliance automation space by focusing on three main pillars of success:
Security first
Centralized collaboration
Ease of Use
Tiebreaker AI delivers, excels, and innovates to help each customer with their compliance automation needs. Are you a medical device manufacturing company or an auditor looking to automate some parts of your MDSAP compliance? Schedule a demo today with the team at Tiebreaker AI!
