October 9, 2018
By Sarah Griffin, Principal Consultant, Brandwood Biomedical (Australia)
Australia is increasingly an attractive market for medical device manufacturers. But medtech companies need to know the complexities of the country’s blended public and private hospital systems to avoid confusion and fully profit from its device reimbursement opportunities.
September 4, 2018
By Michelle Lott, Principal and Founder, Lean RAQA
Don’t let the cash flow slow when new regulatory guidance for medical device manufacturers is handed down by the FDA and other agencies in FY2018. Rather, follow these simple steps that will allow you to get your device to market faster to help your company maximize profit and minimize delays.
August 9, 2018
By David Jensen, Staff Writer, MasterControl
The inclusion of software in medical devices is opening up new avenues for health care treatments. However, it also means medical devices are becoming more complex. New innovations in medical device development should compel device manufacturers to revamp their design and development strategies. More time and effort needs to be spent on design control, risk management and cybersecurity. The increase of software in medical devices will a noticeable impact on the approaches to medical device design and manufacturing.
August 7, 2018
By Julio G. Martinez-Clark, CEO, LATAM Market Access
Don’t get bit by piranhas and crocodiles when entering Latin America’s lucrative $31 billion medical device manufacturing industry. Learn from a pro the tips, strategies and trends you’ll need to be successful in the golden medtech market in North and South America.
July 31, 2018
By Tifany Desprez, Apsalys, a MasterControl Partner
France and Europe are witnessing an explosion of life science innovation from new startups. But what separates the winners from the losers? Learn how to successfully overcome regulatory barriers and get your product to market quicker.
July 12, 2018
By Jerry Chapman, GMP Consultant and Editor-in-chief, Xavier Health
The second part of a two-part blog post that examines the importance of the emerging technology of artificial intelligence and the potential is has to bring about a massive shift in quality management for pharma and medical device manufacturers.
Xavier Health takes a closer look on how to prepare and assess the readiness of your company to implement AI.
July 10, 2018
By Jerry Chapman, GMP Consultant and Editor-in-chief, Xavier Health
FDA officials believe that artificial intelligence (AI) has the potential to bring about a step change in quality management in the pharma and medical device industries. Xavier Health has assembled a team of multidisciplinary experts to take a closer at the possibilities and roadblocks AI presents to quality management in both industries. Part 1 of a two-part series.
July 5, 2018
By James Jardine, GxP Lifeline Editor, MasterControl
Radical, whirlwind change is a core feature of the medical device industry. A clinical/regulatory expert provides insight into the clinical developments currently shaking up the device world and explains how device companies can adapt and thrive in a burgeoning industry that seems to reinvent itself daily.
May 15, 2018
By Terry Walsh, Director APAC, MasterControl
The speed at which the medical device industry is changing and evolving is perhaps unrivaled in the life sciences industry. Medical device manufacturers are experiencing disruption from small companies and startups entering the market1, tech giants like Amazon are investigating and investing in medical device expertise and cybersecurity concerns are on the rise.
April 12, 2018
By David Jensen, Staff Writer, MasterControl
At the beginning of each year, it’s intriguing to look into a crystal ball to get a glimpse of what the upcoming year will look like. Given how fast technology evolves, if you so much as blink you could miss out on critical insight regarding some new trends.
When the medical device excise tax was suspended recently, the industry was left with a sense of déjà vu. Between January 2013 and January 2018, the tax was implemented once and frozen twice. How long will this touch-and-go situation continue?
February 9, 2018
By Jake Walton, Corporate Operations Quality Manager, MasterControl
This blog post is part of an ongoing series to provide the latest tips from experts in the field to help readers keep up with changes in the quality and regulatory industry .
