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Software as a Medical Device: Meeting Clinical Evidence Requirements

March 07, 2024

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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5 Steps to Obtaining ISO 13485:2016 Certification

February 26, 2024

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.

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ISO 62366-1:2015 – Usability Engineering

February 13, 2024

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.

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MasterControl Webinar: Medical Device Quality & Manufacturing Trends

January 31, 2024

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...

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2024 Medical Device Industry Trends

January 22, 2024

Discover the 2024 Trends Shaping Medical Device Quality and Manufacturing

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SeerPharma Sponsoring BioSymposium on Point of Care Diagnostics

April 13, 2023

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...

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White Paper: FDA Guidance: Premarket Cybersecurity in Medical Devices

June 20, 2022

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...

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Medical Devices: Post-Market Surveillance, Adverse Events and Recall

June 01, 2021
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SeerPharma to Sponsor 8th Annual BioMelbourne Device + Diagnostics Lab

February 03, 2020

SeerPharma is excited to be sponsoring BioMelbourne Network’s 8th Annual Device + Diagnostics Lab, to be held on Thursday the 5th of March.

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CSV Assistance for Pharmaceutical and Medical Device Companies

December 09, 2019

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...

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