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.
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Recent Posts
5 Steps to Obtaining ISO 13485:2016 Certification
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.
SeerPharma Welcomes Over 95 Postgraduate Students Studying GMP at UTS
SeerPharma welcomes the 2024 Autumn cohort of students studying Good Manufacturing Practice (GMP) at the University of Technology Sydney (UTS). The program continues to grow from strength to strength, and we’re thrilled to see a record number of enrolments, with over 95 new students joining us this year. The course continues to attract and engage...
ISO 62366-1:2015 – Usability Engineering
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.
2024 Pharmaceutical Industry Trends
MasterControl Webinar: Medical Device Quality & Manufacturing Trends
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...
2024 Medical Device Industry Trends
Infographic: Performance Snapshot for 2023
INFOGRAPHIC: A snapshot of how SeerPharma supported its clients with Quality and GMP Best-Practices in 2023 through QA & GMP Consulting, Auditing, Training and MasterControl "Qx" electronic Quality Management Systems (eQMS) & "Mx" Manufacturing Execution Systems (MES) with electronic Batch Records (eBR).
KENX is a leading knowledge exchange network in the life sciences industry, at the forefront of coordinating and running events focused on making pharmaceuticals and devices safer. The organisation achieves this by bringing together regulators and industry leaders to address the latest industry trends, regulatory changes, business challenges and...
SeerPharma & Melbourne Uni Report: Impact of AI/LLMs on Quality & GMP
SeerPharma engaged with students from The University of Melbourne's Master of Biotechnology program to thoroughly review the academic literature and hold discussions with industry and regulators to develop a comprehensive report investigating the impact of Large Language Models (LLMs) on Good Manufacturing Practice (GMP) and Quality in the...