MDSAP Certification Consultant in Brazil
What is MDSAP Certification?
The Medical Device Single Audit Program (MDSAP) is a globally recognized initiative introduced to simplify and standardize the auditing process for medical device manufacturers. This program allows a single regulatory audit to satisfy the quality management system (QMS) requirements of multiple countries.
By obtaining MDSAP Certification, medical device manufacturers in Brazil ensure compliance with international quality standards, reduce multiple audits, and gain faster market access in participating countries.
Why is MDSAP Certification Important for Medical Device Manufacturers?
- Ensures compliance with ANVISA regulations for medical devices.
- Recognized by five major regulatory authorities (Brazil, USA, Canada, Japan, and Australia).
- Reduces duplication of audits, saving time and cost.
- Enhances trust and global acceptance of medical devices.
- Strengthens ISO 13485 Quality Management System (QMS) compliance.
For medical device manufacturers in Brazil, MDSAP is a key requirement for market authorization with ANVISA.
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International Members that are Participating in the MDSAP Includes:
- USA: Compliance with the FDA’s 21 CFR Part 820.
- Canada: Adherence to the Medical Devices Regulations (CMDR).
- Brazil: Alignment with ANVISA requirements.
- Japan: Compliance with the Pharmaceuticals and Medical Devices Act (PMDA).
- Australia: Conformance with TGA regulatory standards.
By integrating these regulatory frameworks into one cohesive audit process, MDSAP reduces duplication and streamlines compliance efforts, saving both time and resources for medical device companies.
Step-by-Step Guidance Through the MDSAP Certification Process
The MDSAP certification process involves the following steps:
- Training and Preparation: Understand the fundamentals of the Medical Device Single Audit Program (MDSAP training) and its scope.
- Gap Analysis: Identify compliance gaps in your quality management system (QMS) based on the MDSAP standard.
- Audit Support: Implement and monitor corrective actions for seamless certification.
Our experts ensure all regulatory documentation aligns with the requirements of the MDSAP certification process, preparing your team for successful audits.
Benefits of Working with Operon Strategist
- Experienced consultants with global regulatory expertise.
- Strong knowledge of ANVISA MDSAP requirements.
- End-to-end regulatory and documentation support.
- Proven track record of successful certifications.
- Tailored consulting packages for startups and established manufacturers.
How Operon Strategist Helps with MDSAP Certification in Brazil
As a leading medical device regulatory consultant, Operon Strategist offers:
- Gap analysis & QMS implementation for ISO 13485 and ANVISA requirements.
- Preparation and submission of MDSAP documentation.
- Internal audits and mock inspections to prepare manufacturers for ANVISA audits.
- Regulatory training for compliance with international standards.
- Complete support from audit readiness to certification approval.
With our expertise, medical device manufacturers in Brazil can achieve MDSAP Certification efficiently and confidently.
FAQ
What is MDSAP Certification?
MDSAP Certification is a program that allows medical device manufacturers to undergo a single audit that meets the requirements of multiple regulatory authorities, including ANVISA in Brazil.
Does MDSAP replace ISO 13485 certification?
No. MDSAP is based on ISO 13485 QMS requirements but also includes additional country-specific regulatory needs.
How long does it take to obtain MDSAP Certification?
The timeline depends on the readiness of your QMS. On average, it takes 6–12 months including audits, documentation, and corrective actions.
How can Operon Strategist help in achieving MDSAP Certification?
We provide consulting, documentation, internal audits, and complete regulatory guidance to help medical device manufacturers in Brazil meet MDSAP requirements successfully.