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The European Directives on medical devices have been replaced by a Medical Device Regulation (MDR), which came in to effect April 2017.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.
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.
A major Australian manufacturer of medical devices has engaged with SeerPharma to deliver a customised program on computer system validation (CSV). The course looks to address content such as agile processes, cloud computing and automated testing drawing on SeerPharma’s experience with the regulatory (GMP) framework and incorporating case studies...
We invite you to attend our inaugural SeerPharma Symposium, which will be held at the Park Hyatt, in Melbourne on Friday the 20th of May.
After 25 years of serving pharmaceutical and medical device professionals in the Asia-Pacific region, we would like bring all of you under the one roof. With this in mind, we’d like the day to focus on “How you...
Your quality systems and procedures are in place, however no matter how much you try, people still don’t fully comply with them. These deviations and subsequent investigations lead to lost productivity. Typically you identify “human error” as the root cause and your corrective action is to train your team.
Copyright © SeerPharma
