MDSAP Audit Services

Pro QC is a Global Quality Assurance company that provides MDSAP (Medical Device Single Audit Program) audit services in over 88 countries. With over 40 years of experience in auditing, Pro QC is a trusted partner for businesses that need to improve their MDSAP audit readiness.

MDSAP is a program that consolidates regulatory inspections across the globe. By complying with a comprehensive cycle of audits under MDSAP, a company can meet the regulatory requirements of multiple countries and jurisdictions. These jurisdictions currently are:

  • The United States Food and Drug Administration
  • Japan’s Ministry of Health, Labour and Welfare
  • Brazil’s Health Regulatory Agency (ANVISA)
  • Australia’s Therapeutic Goods Administration
  • Canada’s Health Canada

Companies complying with MDSAP save time on regulatory audits and remediation, have a more predicable audit schedule, and can certify their device to all five national regulatory agencies in order to save tremendously on time and costs.

Pro QC’s MDSAP audit services will help any medical device company in preparing for an MDSAP certification. In addition, Pro QC also helps to ensure supplier compliance with MDSAP, further enhancing the company’s ability to meet regulatory requirements.

Improve quality and regulatory compliance practices, identify and address potential risks and gaps in your systems

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MDSAP Audit Approach

Pro QC’s MDSAP audit services are conducted by qualified auditors with years of auditing experience. Our technical expertise and ability to provide custom-made solutions stand out as an asset for organizations that need to evaluate their current compliance level with the standard, prepare for an MDSAP certification, or improve their quality management system.

Our on-site audits are based on factual observations and are designed to be impartial. During an MDSAP audit, the auditor collects evidence on the current compliance level of the organization against the MDSAP standard. Once the audit is completed, the auditor will provide a list of strengths and opportunities for improvement identified during the audit that are ranked in order of importance and impact. The auditor will provide an overall assessment and score and can develop a detailed corrective action plan so clients will reach their goals successfully. Audit results, recommendations, and photographic evidence are included in the final audit report.

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What is an MDSAP Audit?

MDSAP was conceived in 2012 by the International Medical Device Regulators Forum, which recognized the benefits of reducing compliance costs and approval timelines in medical device manufacturing, potentially leading to reduced overall healthcare system costs. From 2014 to 2017, the five national agencies piloted the single audit program and produced a report with positive results indicating, “the MDSAP Pilot had satisfactorily demonstrated the viability of the Medical Device Single Audit Program.”

The US FDA now “accepts MDSAP audit reports as a substitute for routine Agency inspections.” Participating medical device manufacturers have responded positively, saying, for example, that the program “has allowed us to consolidate the global regulatory assessment process across multiple international locations, reducing internal costs while increasing the overall predictability of these efforts across our global footprint. By minimizing disruption to our business, we can focus on delivering the safest, most effective and technologically advanced products possible.”

MDSAP also benefits regulators, since multiple national agencies do not have to deploy inspectors to the same company on the other side of the planet to perform a largely similar audit. Its requirements are aligned with ISO 13485:2016 (Medical devices — Quality management systems — Requirements for regulatory purposes), the audit structure is similar to FDA’s quality system inspection method, and a risk-based approach is emphasized. Regulators also benefit by aligning their regulatory approaches, improving the consistency and predictability of their audit programs, and avoiding deploying resources in a duplicative way.

An MDSAP audit is conducted by an independent third party to verify compliance with the regulations of one or more of the five participating countries. This demonstrates to current and future clients that the supplier has the systems in place to produce safe and effective medical devices. A third-party audit provides objectivity that a self-examination or a client audit cannot.

MDSAP is based on a three-year audit cycle:

  • An initial audit is a complete audit of the medical device manufacturer’s QMS.
  • A surveillance audit is conducted in year 1.
  • Another surveillance audit is conducted in year 2.
  • A recertification audit is conducted in year 3.

Pro QC’s MDSAP audit checklist reflects the regulatory agencies’ own published guidance and is comprised of:

  • Management
    • Includes QMS planning, implementation, and the quality manual; quality policy, and document and record controls
  • Device marketing authorization and facility registration
    • Includes facility registration and evidence of marketing approval
  • Measurement, analysis and improvement
    • Includes investigation of nonconformity, corrective and preventive action, internal auditing, treatment of complaints, and adverse event reporting
  • Medical device adverse events and advisory notices reporting
    • Includes notification of adverse events and notification of advisory notices
  • Design and development
    • Includes design and development planning, design input and output verification, design validation, design review, and top management commitment to the design and development process
  • Production and service controls
    • Includes control of product cleanliness, infrastructure, process validation, competence of personnel, validation of software, device master file, acceptance activities, and risk controls applied to transport, installation, and servicing
  • Purchasing
    • Includes selection of supplier files to audit, extent of controls applied to the supplier, verification of purchased products, and purchasing control activities as a source of quality data for the measurement, analysis, and improvement process

 

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What are the benefits of MDSAP participation?

Participating in the MDSAP helps a medical device manufacturer in these ways and more:

  • A single audit can satisfy the requirements of five national regulatory jurisdictions.
  • The medical device manufacturer can spend less time hosting audits, addressing nonconformances, and varying technical requirements.
  • Audits are scheduled and mapped out.
  • Requirements and audit procedures are transparent, as described in exhaustive detail in FDA’s “MDSAP Audit Approach” document and MDSAP companion documents page.

Note that some disadvantages to a medical device manufacturer participating in MDSAP may include:

  • The European Medicines Agency and China’s FDA do not participate.
  • Regulators can still conduct unannounced inspections, follow-up audits, or enforcement inspections.
  • Auditing Organizations are still required to conduct unannounced manufacturer audits as part of the audit cycle.

In general, the medical device manufacturer should choose whether to participate in MDSAP based on which countries they plan to market the device in.

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Pro QC’s MDSAP Audit Outcomes

Solid pathway to compliance

MDSAP requires a definitive audit cycle from an approved “MDSAP Auditing Organization.” Pro QC International provides MDSAP audits to identify noncompliance and provides CAPA plans. We support our clients in ensuring they comply with the requirements of MDSAP before this definitive audit sequence begins.

Audit report delivered within 72 hours after the service

Pro QC clients can expect an organized MDSAP audit report delivered within 72 hours after the service and presented in exhaustive detail. Each report provides:

  • A summary of the audit
  • The overall audit score and compliance level with MDSAP
  • The compliance level for each part of the regulations. Each finding is explained in clear language and is color-coded.
  • The recommended corrective actions to implement
  • Objective evidence such as photos, interviews, and examined records and documents

Corrective action plan

The MDSAP audit is only the first step. If the compliance level is subpar, a corrective action plan should be developed and implemented to effectively improve the QMS performance sustainably. Pro QC helps the audited organization reach full compliance by:

  • Performing an MDSAP audit
  • Establishing a corrective action plan
  • Verifying corrective action implementation through detailed follow-up activities
  • Controlling performance and facilitating continuous improvement.

 

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Invest in quality and compliance with Medical Device Single Audit Program: A comprehensive approach for minimizing risks and maximizing success

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