Quality Assurance (QA) is an essential process in Life Sciences organizations, regardless of their size. It involves ensuring that products, services, and processes meet specific standards, and regulations, and meet the needs and expectations of cust...
2023 is almost up and it’s time to plan for 2024. With the number of innovations and news happening in the medical device industry right now, there should be plenty of opportunities to be inspired and participate in fruitful discussions in upcoming e...
Are you worried about writing a change control document for organization-wide change? It’s normal that this can feel like a gut-wrenching process sometimes. After all, change management is no easy task! The bigger the organization, the more arduous t...
Most pharma and MedTech companies have had digital transformation on their to-do list for quite some time. Unfortunately, only a few (roughly 20%) have actually pivoted from doing digital to being digital.
Medical devices on the market are under strict surveillance by governing bodies such as the FDA. As with all tech nowadays, the Medical Device industry is evolving at hyperspeed, and regulations need to constantly keep up to date in order to continue...
In the Life Science industry, the race is on to earn the prestigious ISO 13485 certification as soon as possible, since it prepares companies for the future EU MDR audit. If you're in the life science industry and after the ISO 13485 certification, t...