Medical Device Single Audit Program (MDSAP) Consulting Services
Operon Strategist offers expert MDSAP compliance consulting services to help medical device manufacturers streamline global market entry. Our team of experienced MDSAP consultants ensures your Quality Management System (QMS) aligns with ISO 13485:2016 and meets the regulatory expectations of the USA, Canada, Brazil, Japan, and Australia. From gap analysis, documentation, and implementation support to pre-audit and certification guidance, we make the entire process seamless and efficient. With Operon Strategist as your compliance partner, you can achieve faster certification, reduced audit risks, and full regulatory confidence across multiple markets.
What is MDSAP Certification?
The Medical Device Single Audit Program (MDSAP) is a global initiative designed to streamline the regulatory compliance process for medical device manufacturers. It allows a single regulatory audit of a manufacturer’s Quality Management System (QMS) that satisfies the requirements of multiple international regulatory authorities.This program was developed by the International Medical Device Regulators Forum (IMDRF) and enables third-party auditors to evaluate a manufacturer’s compliance with ISO 13485:2016 along with additional country-specific regulatory requirements through just one audit process.
The Benefits of MDSAP Certification
MDSAP (Medical Device Single Audit Program) offers medical device manufacturers a unified audit process that meets the regulatory requirements of multiple countries in one go. Here’s why MDSAP is becoming essential:
Key Benefits of MDSAP:
- Unified Audit Process:
Meet regulatory expectations across major markets (USA, Canada, Brazil, Japan, and Australia) with just one audit. - Streamlined Operations:
Minimize disruptions with predictable audit timelines and fewer inspections. - Improved Market Access:
Enter multiple global markets faster and ensure quicker patient access to medical devices. - Resource Optimization:
Use time and team resources more efficiently by avoiding multiple audits. - Cost-Effectiveness:
Reduce costs by consolidating audits instead of handling them separately. - Transparency & Accountability:
Boost clarity in your QMS and regulatory processes with more structured evaluations. - ISO 13485 Alignment:
Achieve full compliance with ISO 13485 and country-specific regulations through a single audit approach.
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Regulatory Authorities Included in MDSAP
- Australia (TGA: Therapeutic Goods Administration of Australia)
- Brazil (ANVISA: Brazil’s Agência Nacional de Vigilância Sanitária)
- Canada (Health CANADA)
- Japan (MHLW: Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency)
- USA (FDA: Food and Drug Administration)
MDSAP vs ISO 13485: Key Difference
MDSAP has more stringent requirement than ISO13485. ISO 13485 and MDSAP two different programs with similar requirement. the devices are used in the healthcare industry and pharma industry with the end users being humans so ISO13485 MDSAP standards look to ensure that medical device manufactured to strict quality requirements. Companies that participate in the MDSAP program must undergo an audit to ensure compliance with both regulatory and ISO 13485 requirements in order to profit from the program.
Our Role in the MDSAP Certification Process
At Operon Strategist, we support medical device manufacturers throughout the MDSAP certification journey with a structured and effective approach:
1. Understanding Your Goals: We begin by discussing your organization’s objectives and the benefits of MDSAP certification. Based on your requirements, we offer a customized proposal tailored to your company’s compliance needs.
2. Project Planning & Pre-Audit: Our team conducts a pre-audit to assess your current Quality Management System (QMS) and identify potential gaps. This step helps us develop a detailed project plan and schedule for audit readiness.
3. QMS Assessment & Implementation: We assist in implementing or upgrading your QMS to meet MDSAP and applicable regulatory requirements.
Our services include:
- Training your team on compliance requirements
- Assisting in documentation preparation and review
- Ensuring alignment with ISO 13485 and country-specific standards
4. System Evaluation & Certification: Once your system is ready, we guide you through the official audit process. Upon successful assessment and auditor approval, your organization receives the MDSAP certification.
Why Choose Operon Strategist for MDSAP Certification?
Operon Strategist is a trusted consulting partner for medical device manufacturers aiming for MDSAP certification. We offer end-to-end support tailored to your business needs, helping you meet global regulatory requirements efficiently and effectively.
What We Offer:
- Gap Analysis to identify compliance issues early
- Customized Compliance Strategies based on your product and target markets
- Documentation Support to align with ISO 13485 and country-specific regulations
- Mock Audits & Readiness Assessments to ensure audit preparedness
- Staff Training on MDSAP processes and regulatory expectations
With in-depth knowledge of international regulations, we help you reduce audit risks, improve quality systems, and unlock access to major markets like the USA, Canada, Brazil, Japan, and Australia.
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FAQ
What is MDSAP?
The Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to undergo a single regulatory audit that covers the requirements of multiple countries, including the USA, Canada, Brazil, Japan, and Australia.
Who needs MDSAP certification?
Medical device manufacturers seeking market entry into MDSAP-participating countries, such as the US, Canada, Brazil, Japan, and Australia, should obtain MDSAP certification to streamline compliance.
What are the benefits of MDSAP?
MDSAP simplifies regulatory audits, reduces compliance costs, minimizes redundant inspections, and improves global market access for medical devices.
How long does it take to get MDSAP certified?
The MDSAP certification process typically takes 6 to 12 months, depending on the complexity of your QMS and regulatory readiness.
How can Operon Strategist help with MDSAP compliance?
Operon Strategist provides comprehensive consulting, including gap analysis, regulatory documentation, internal audits, and training to ensure successful MDSAP compliance.