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.

Medical device UDI

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 510k

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.

FDA QMSR final rule

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

FTE Model Explained

Explore what is FTE model, how Elexes's FTE model works, and what services do we offer as a FTE Partner.