For most medical device manufacturers, the roadmap to market will start with ISO 13485:2016 certification. Obtaining an ISO 13485:2016 certificate is evidence that the Quality Management System in place is compliant with international standards and is a key component of a registration package with the regulators.
Research and operations of Medical Technology, Biotechnology and Pharmaceutical (MTP) companies aligned with and in some cases certified to Quality Management System (QMS) Standards will ensure Australia is at the forefront of medical innovation.
A global provider of medical device implants approached SeerPharma to conduct an internal ISO 13485 audit of their operations.
SeerPharma has assisted an Australian 3D Printing Medical Device company to develop an ISO 13485 compliant Quality Management System (QMS).
As a Medical Device company, you are required to investigate the cause of quality failures or production problems. Surprisingly though, “Failure to thoroughly investigate…” is a common finding from quality (management) system inspections and audits against FDA 21 CFR Part 820 and ISO 13485.
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