I'm looking forward to this course. RAPS has a lot of good general topic courses, but I miss more detailed issues specific courses, as a resource for RA professionals in smaller biotech who wear many hats ...

Hi Please include my number to the group: 7205103373 Regards, Sonali Mohapatra CONFIDENTIALITY NOTICE: The contents of this email message and any attachments are intended solely for the addressee(s) ...

Hello Anon, It depends on the device, as generally the Day, Month, and Year would be included so a user knows the time span from date of manufacture precisely. Though in my experience, if the devices ...

Currently, in the US House and Senate, a potential BIOSECURE Act is on the table. This Act while not finalized or implemented yet, will likely affect US drug and biotech companies and their relationships ...

Interestingly, the Swiss trade organization Swiss MedTech, just issued an informal guidance on medical devices not planning to transition to the EU MDR and "placing on the market." This is not from a regulator ...

As a general rule, yes. This is because: form templates are generally considered to be Tier 2 documents (procedures), a management review procedure is required by ISO 13485, and procedures are documents ...