Regulatory

The European Commission published a new guidance document that clarifies certain requirements originally outlined in MDCG 2020-4: Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions.1 The new guidance clarifies the...

Nanotechnology is the science of understanding, inventing, and controlling objects which are built in the scales of nanometers (one nanometer is one-billionth of a meter). Using Nanotechnology, manufacturers can compose components such as batteries, robots, or tools at a very...

If your medical device has contact with human tissue, it is a safe bet that you will be required to conduct biocompatibility testing. Biocompatibility testing is used to determine the “potential for an unacceptable adverse biological response resulting from contact...

Health Canada released a notice for the stakeholders of the medical device and drug industry to help them understand the tenure of the interim orders released during the pandemic.1 Since March 2020, Health Canada released five interim orders each of which...

Biosimilars are biological products that are composed or produced in living systems such as yeast or bacteria. They are defined as the medicinal drugs which function exactly like certain existing and approved drugs, often referred to as “reference product”. The...

December is HIV/AIDS Awareness Month, and given the state of our current global pandemic, now is a great time to look back on the victories and mistakes made in dealing with the HIV/AIDS crisis. The HIV/AIDS crisis was at the...

The FDA published 21 CFR Part 11 in 1997 to regulate electronic records and electronic signatures. Technology has advanced considerably since 1997, but the regulation still applies and is more critical than ever. Due to the COVID-19 pandemic and most...

Cloud Computing is speeding up the way we create, share, and view data. With features such as multiple backups, high security, remote access, and auto-scalability, this platform of virtual computing is assisting health care providers and medical device manufacturers to...

If you have ever wondered exactly what role the FDA has in mammography and breast cancer screening, you are not alone. How the FDA regulates technology such as this can get complicated easily when you consider all the different aspects...