SeerPharma has over 30 years of experience, supporting diagnostic manufacturers and laboratories on matters related to Quality and GxP compliance. In that time , we’ve seen the emergence and importance of Point of Care Diagnostics (POCD). Following this trend, we’re delighted to be sponsoring an upcoming Biosymposium by the Biomelbourne Network...
In 2014, the FDA issued a guidance document for the Management of Cybersecurity in Medical Devices – Content of Premarket Submissions. Since then, technologies and the interconnectivity of medical devices have evolved rapidly. In response, the FDA released a new draft guidance in April 2022, for comment purposes only - Cybersecurity in Medical...
SeerPharma is excited to be sponsoring BioMelbourne Network’s 8th Annual Device + Diagnostics Lab, to be held on Thursday the 5th of March.
Several pharmaceutical and medical device manufacturers in the Asia-Pacific region have approached and engaged SeerPharma for assistance on matters related to Computer System Validation (CSV). Typical requests have seen SeerPharma address computer systems validation approaches to meet the regulatory requirements of Annex 11 of the PIC/S Guide to...
A major sponsor and distributor of medical devices in Australia engaged SeerPharma to conduct a gap assessment of it’s Quality Management System and Operations against ISO 13485:2016. The client's current operations are licensed to ISO 9001:2015 and required assistance from SeerPharma to understand what would be required to upgrade their QMS to...
The stages required for applying ISO 14971 principles to risk management for medical devices can be typically broken into 6 steps:
The European Directives on medical devices have been replaced by a Medical Device Regulation (MDR), which came in to effect April 2017.
SeerPharma’s inaugural Symposium was a great success with Operational and Quality Directors from over 30 Pharmaceutical and Medical Device / Medical Technology companies such as CSL, Patheon, Alere Medical and MSD in the crowd.
The SeerPharma team has been busy implementing electronic Quality Management Systems (eQMS) for a variety of companies ranging from pharmaceutical, nutraceutical, veterinary and medical device companies.
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