ISO Services
MDSAP Consultancy Services for the Life Science Industry
At QAEC Limited, we provide expert quality and regulatory consultancy services to medical device companies, helping them successfully navigate the Medical Device Single Audit Program (MDSAP) and achieve MDSAP certification.
We help ensure that your medical devices meet the stringent requirements of multiple global markets, including the US, Canada, Brazil, Australia, and Japan, through a single audit process. With our proven expertise, we streamline your path to MDSAP certification, enabling efficient market access while maintaining the highest quality standards.
Our MDSAP Services
- MDSAP Audit Preparation: Comprehensive audit readiness support, including gap assessment, documentation review, and risk management strategies.
- Quality Management Systems (QMS): Implementation and optimisation of QMS in compliance with ISO 13485 and MDSAP requirements.
- Gap Assessment: Conduct a comprehensive gap assessment for MDSAP to identify compliance gaps across multiple regulatory frameworks.
- Regulatory Submissions & Compliance: Assistance with global regulatory submissions, ensuring alignment with MDSAP standards for key markets.
- Audit Support: End-to-end support during the MDSAP audit process, including addressing audit findings and post-audit actions.
- Post-Market Surveillance: Ongoing regulatory and quality support to maintain compliance after MDSAP certification.
Why Choose Us?
- Proven success in MDSAP certification for life science companies.
- Expertise in global regulatory compliance and ISO 13485 standards.
- Tailored solutions to meet the unique needs of your business.
- Full support throughout the audit process, ensuring a smooth path to certification.
- We offer a strategic approach and solutions.
- We are your trusted partner for MDSAP success.
- Our consultancy services are tailored to meet your needs at competitive and cost-effective rates.
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Helping life science and manufacturing companies to take it to the next level
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