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.
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.
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.
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.
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.
By James Jardine, GxP Lifeline Editor, 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.
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.
If you haven't digitized yet, it's hurting the bottom line. As reported by Deloitte, digitally mature companies are, "about twice as likely as lower-maturity ones to report net profit margins an annual growth significantly above their industry average." Here's a look at five critical ways that paper-based processes are eating into revenue.
