What is the difference between ISO 13485 and MDSAP?

ISO 13485 and MDSAP are two different programs with similar requirements, but they do not duplicate each other. MDSAP has the more stringent requirements of the two, and companies that are already certified to ISO 13485 will see an increase in the number of audit days once they seek certification to MDSAP.

What countries require MDSAP?

Make use of the MDSAP if you are a manufacturer of medical devices. In this special programme for medical devices, which includes the US, Canada, Brazil, Australia, and Japan, you can submit for a single evaluation of your quality management system (QMS).

Does FDA recognize MDSAP?

MDSAP audit reports are accepted by the Food and Drug Administration (FDA) in place of FDA Establishment Inspection Reports (EIRs).

What is the objective of MDSAP?

It is a regulatory auditing programme that four countries initially created cooperatively. MDSAP is exceptional in that it enables a medical device maker to conduct a single quality management system audit to meet the standards of all involved regulatory authorities.

What is MDSAP for medical devices?

The Medical Device Single Audit Program allows an Auditing Organization authorised by MDSAP to perform a single regulatory audit of a manufacturer of medical devices that complies with the pertinent specifications of the regulatory bodies taking part in the programme

What is the audit cycle of MDSAP?

The MDSAP is built around a three-year audit cycle, starting with a Stage 1 and Stage 2 audit of the manufacturer's QMS. Audit of Partially Surveillance in each of the ensuing two years. A thorough re-audit, also known as a recertification audit, is performed in the third year

MDSAP - Medical Device Single Audit Program (Expert MDSAP Consulting and QMS Services)

The Medical Device Single Audit Program (MDSAP) is a globally recognized framework that simplifies regulatory audits for medical device manufacturers. At Operon Strategist, we specialize in providing comprehensive MDSAP consulting services, helping companies achieve certification with ease and gain access to international markets, including the USA, Canada, Brazil, Australia, and Japan.

What is MDSAP Certification?

The MDSAP certification allows medical device manufacturers to meet regulatory requirements of multiple countries through a single audit. It ensures compliance with standards like ISO 13485 while addressing country-specific regulations. Participating countries include:
- United States: FDA compliance.
- Canada: Health Canada certification.
- Brazil: ANVISA regulatory requirements.
- Australia: TGA market access.
- Japan: MHLW/PMDA compliance.
By obtaining MDSAP certification, manufacturers simplify their compliance processes and gain a competitive edge in global markets.

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Why is MDSAP Certification Essential for Medical Devices?

MDSAP certification provides several advantages:

Streamlined Compliance: A single audit covers multiple regulatory standards, saving time and resources.
Market Expansion: Facilitates access to key international markets, including Canada, Brazil, and Japan.
Improved Credibility: Demonstrates a commitment to quality and global regulatory compliance.
Regulatory Confidence: Strengthens your position with regulatory authorities like the FDA and Health Canada.

For manufacturers targeting global markets, achieving MDSAP certification for medical devices is a crucial step toward sustained growth and success.

Our MDSAP Consulting Services

At Operon Strategist, we offer tailored solutions to simplify the MDSAP certification process:

Gap Analysis: Identify areas needing improvement for compliance.
Document Preparation: Assist with ISO 13485 documentation and regulatory submissions.
Pre-Audit Preparation: Conduct mock audits to ensure readiness.
Audit Support: Provide on-site and remote guidance during audits.
Post-Audit Assistance: Help address findings and implement corrective actions.

Benefits of Partnering with Operon Strategist for MDSAP Certification

Custom Strategies: Our team designs compliance plans tailored to your operations.
Regulatory Expertise: We have in-depth knowledge of ISO 13485 and global requirements.
Efficient Processes: Minimize certification timelines and maximize outcomes.
Ongoing Support: We ensure compliance even after certification is achieved.

By partnering with us, you can achieve MDSAP certification for medical devices smoothly and confidently.

Why Choose Operon Strategist for MDSAP Certification?

With extensive experience in medical device regulatory consulting, Operon Strategist is your trusted partner for MDSAP certification. We provide comprehensive support, including gap analysis, documentation refinement, and personalized compliance strategies tailored to your business needs. Our team conducts mock audits, readiness assessments, and focused training to ensure your organization is fully prepared for certification.

With a deep understanding of global regulatory frameworks, we simplify the certification process, saving you time and resources while ensuring seamless compliance. Trust Operon Strategist to make your MDSAP journey efficient, stress-free, and successful.

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Frequently Asked Questions (FAQs)

Q: What is the scope of MDSAP?
A: The MDSAP certification process evaluates compliance with ISO 13485 and country-specific regulations for participating countries.

Q: How long does it take to get MDSAP certification?
A: Typically, it takes 3-6 months, depending on your organization’s preparedness.

Q: Is MDSAP mandatory for medical devices?
A: MDSAP is mandatory for devices sold in Canada and beneficial for accessing other markets.

Q: Can Operon Strategist assist with post-audit compliance?
A: Yes, we offer full post-audit support to address findings and maintain compliance.