Onshore vs Offshore Staffing Model
Explore the pros and cons of each model and see the factors you should use to determine which model is best for your medical device company.
The Medical Device Manufacturer’s QRG to UDI (Unique Device Identification)
A Short but complete comprehensive guide to medical device UDI (Unique Device Identification) from what it is to what are the penalities for non-compliance.
FDA 510(k) Submission, Review Process & Mistakes to Avoid
Learn everything about FDA 510(k). Right from Factors to consider, FDA timeline, to mistakes to avoid, learn all this about FDA 510(k) submission.
The FDA Issues QMSR Final Rule
The FDA has issued the QMSR final rule as a step towards global harmonization. Find out everything about the rule here along with the transition period announced.
FTE Model Explained
Explore what is FTE model, how Elexes's FTE model works, and what services do we offer as a FTE Partner.
Components of EU PIF
Let's understand all the essential components of EU PIF (Product Information File)
