SeerPharma Blog listing page

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 In response, the FDA released a new draft guidance in April 2022, for comment purposes only - Cybersecurity in Medical...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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SeerPharma Engaged by Medical Device Companies to Assist with QMS

March 14, 2019

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...

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Application of ISO 14971 Risk Management to New Medical Devices

February 08, 2018

The stages required for applying ISO 14971 principles to risk management for medical devices can be typically broken into 6 steps:

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Assistance with New Medical Device Regulation (MDR) in Europe

August 01, 2017

The European Directives on medical devices have been replaced by a Medical Device Regulation (MDR), which came in to effect April 2017.

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SeerPharma Symposium: Funding for Pharmaceuticals and Medical Devices

October 25, 2016

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. 

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Pharmaceutical and Medical Device QMS Solutions

August 31, 2016

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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