The power to control one’s health is shifting more each day from life sciences companies and healthcare organisations to the consumers themselves. Never have consumers had so many options for personalised therapies or greater control over their well-being.
A multinational manufacturer of cardiovascular devices recently engaged SeerPharma to conduct a comprehensive mock US FDA audit of their operations in Singapore. The audit was conducted against US FDA 21 CFR Part 820 – Quality System Regulation (21 CFR 820). SeerPharma reviewed relevant documentation remotely and then spent three days on-site...
The inclusion of medical devices onto the Therapeutic Goods Administration's (TGA’s) Australian Register of Therapeutic Goods (ARTG) requires manufacturers to demonstrate that their device meets specific safety and performance characteristics and has been designed and manufactured in accordance with the Essential Principles.
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.
As medical devices become more sophisticated, adaptable to technological advances and accessible to the public, it is critical that companies ensure they have developed a robust program of usability engineering, to minimize the risk of incorrect usage, and create devices that are easy to use, intuitive and safe.
SeerPharma are strategic partners with market leading software solution provider – MasterControl. Our partnership, over the last 7 years, has seen us deploy this solution to digitise Quality and Manufacturing workflows to over 75 companies.
MasterControl is running a webinar on current industry trends facing Quality and Manufacturing professionals...
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...
Copyright © SeerPharma
