The final date for all MDD-certified devices to be certified under the new MDR is May 25, 2024. Once a medical device is EU MDR compliant (even prior to this date), it can be certified under the MDR. However, it is not mandatory to obtain EU MDR cert...
Medical Device Development Phases According to Regulations Medical device development is an inherently complex process with increasingly rigid requirements that must be met for FDA approval and/or EU MDR compliance.
Tech innovations are driving the rapid evolution of everything humans do, and auditing is no exception. Since 2020, remote or virtual audits have become commonplace, born out of necessity in a time when on-site audits were simply impossible. Due to t...
Stacks of paper, what a hassle! Staying on top of who printed what, where, and when is a common struggle for many life science companies. Document reconciliation is even more of a challenge. Printing may be unavoidable, but staying compliant and keep...
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.
Scilife has a new module! Finally, risk management is made a whole lot simpler, as well as accessible by everyone. In our webinar on Scilife's new Risk Assessment module, CEO Filip Heitbrink discusses:
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...
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