Documents

If you’re a medical device manufacturer planning do to business with the European Union you need to know about the regulatory change that took place in May 2018 that could have operational process and financial implications for your business. The new General Data Protection Regulation (GDPR) contains both existing and new data privacy requirements that, if not met, can result in significant fines of up to 20 million Euro or four percent of annual turnover. Maintaining compliance is required of...

Last year the US medical device industry achieved over $150 billion in sales, making it one of the most lucrative industries in the country. However, launching a medical device start-up in this highly regulated industry can be fraught with challenges. Medical product start-ups need to minimize regulatory and compliance risk to attract early-stage investors and save money. To complicate matters even more, recent changes in FDA regulations make it more important than ever to limit potential...

Every responsible medical device manufacturer is aware that the FDA requires them to establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications – a protocol known as current good manufacturing practices (CGMP). These requirements were written into the original regulation issued back in 1978, which was revised, starting in 1990, into a broader and more consistent quality system (QS) regulation that is in effect today. Of...