Like any other regulated product, your medical device must be properly labeled. But do you know how to prepare a medical device label and which regulations your label has to comply with? And how about which ISO standards can help you meet these regul...
In addition to meeting rigorous safety requirements, medical device manufacturers must also comply with strict quality standards. That is why a compliant Quality Management System (QMS) is fundamental to any Life Sciences company operating in the tig...
No doubt the world has changed in recent years. Yet innovation in the medical field is stronger than ever.
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...
Recently, our Scilife CEO Filip invited Mika Siitonen, Medical Development Manager at Labquality and seasoned expert in medical device regulatory guidelines, to answer anything and everything you wanted to know about performing Risk Management under ...
How much do you know about Medical Device Coordination Group Documents? You may be more familiar with their abbreviation: MDCG. Developed on behalf of the European Commission, MDCG Documents are designed to help manufacturers understand how the Medic...
In the medical device industry, there are tons of abbreviations. And as a medical device professional you can easily get lost in this acronym ocean! The most important (and most confusing) abbreviations are DHF, DMR, and DHR. These three abbreviation...
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.
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