For more than 35 years, SeerPharma has partnered with organisations involved in the supply, manufacture, and distribution of Medical Devices and In Vitro Diagnostics (IVDs) across the Asia-Pacific region.
Our team supports companies that design, develop, and manufacture medical devices and IVDs across of all classifications, helping ensure their processes are fully documented, controlled, and compliant with the expectations of international regulatory authorities.
Through our partnership with MasterControl, we also assist clients in digitising and automating quality and compliance workflows, enabling more efficient management of documentation, training, audits, and other key quality system activities.
Growing Demand for Independent Internal Audits
Leveraging our extensive experience in Quality Management Systems (QMS) and GMP-compliant operations, SeerPharma has seen a growing number of medical device companies engage our team to conduct independent internal audits as part of their ongoing compliance and continuous improvement programs.
Over the past year alone, our consultants have performed internal audits for companies involved in the development and manufacture of a diverse range of technologies, including:
- Interventional surgical stents
- Smart medical devices (SaMD) for respiratory health
- Point-of-care diagnostic systems
- Cardiac pacemakers
Our clients represent a broad spectrum of maturity—from early-stage innovators preparing for regulatory submissions, to established manufacturers with products already commercialised in major markets such as the United States and the European Union.
Compliance Frameworks and Standards
Each engagement is tailored to align with the specific requirements of the client’s QMS. SeerPharma’s internal audits are typically conducted against internationally recognised standards and regulations, including:
- ISO 13485:2016 – Medical Devices Quality Management Systems
- 21 CFR Part 820 – FDA Quality System Regulation (QSR)
- MDSAP AU P0002 Medical Device Single Audit Program (MDSAP) Audit Approach
By engaging SeerPharma, clients benefit from independent, experienced, and objective assessments of their quality and compliance systems—helping identify gaps, verify compliance, and support readiness for external regulatory or certification audits.
Learn More
Contact Us if you would like to discuss how our team can support your next internal audit or quality system review.
