At a previous PDA/FDA Joint Regulatory Conference in Washington, D.C, Donna Gulbinski, quality and regulatory affairs expert, provided useful information about the future of quality management. She identified some key strategies for how your organization can identify and understand quality assurance trends and develop initiatives for long-term success.
December 15, 2020
By Quality Team Member, Cannon Quality Group
Three key trends in MedTech quality management for 2021 include a rise in eQMS adoption, the continuation of remote audits and an increase in shared supplier audits.
December 9, 2020
By David Jensen, Staff Writer, MasterControl
With the fast-approaching Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), medical device manufacturers will be seeing more documentation requirements. One of the new documents is a summary of safety and clinical performance (SSCP). This is one of the annual reports manufacturers must provide throughout the life cycle of a device in order to remain compliant to sell products in the EU.
November 9, 2020
By Sarah Beale, Staff Writer, MasterControl
On 30 July 2020, we celebrated the 17th anniversary of the completion of the Human Genome Project (HGP). It took scientists 13 years to map and sequence all human genes, a staggering feat of modern science.
November 5, 2020
By Sarah Beale, Staff Writer, MasterControl
For regulated companies, there’s a whole lot riding on training. If someone isn’t trained or is trained improperly, the life-saving products of life sciences companies can become life-ending products.
November 3, 2020
By James Jardine, Staff Writer, MasterControl
To keep pace with the technological and scientific advancements that continue to shake up the pharmaceutical industry, companies are increasingly finding it necessary to adapt their strategies, procedures and business practices.
MasterControl’s cloud-based quality management system (QMS) is now available in Australia. An increasing number of businesses are modernising their operations and discovering the advantages of cloud computing. Explore the ways cloud technology makes it possible to enhance your competitive edge.
August 27, 2020
By Grant Bennett, CEO, Brandwood Biomedical
Despite a virtual kaleidoscope of continual regulatory fluctuations, 2019 presents some potentially very attractive market expansion opportunities in Asia-Pacific, including China, India, Australia and Japan. Get a comprehensive overview of device markets and their promising potential.
August 20, 2020
By Luana Carone, Solutions Consultant for Australia/New Zealand, MasterControl
It’s said that change is never easy. But in the pharmaceutical industry, flexibility, and adaptability are part and parcel of successfully delivering the safest, highest quality products to a global market.
August 5, 2020
By Belinda Dowsett, Quality Assurance Manager and Consultant
So much can change over a nearly 20 year period. Since the Australian Regulatory Framework for medical devices was adopted in 2002, the use and accessibility of software in medical applications has advanced beyond expectation.
