While the current EU Medical Device Directive 93/42/EEC (as amended by Directive 2007/47/EC – “MDD”) primarily focusses on the pre-approval stage of a medical device and how the manufacturer can ...

As the biopharma space gets more competitive and the days of blockbuster drugs seem further in the rearview, biopharma companies are investing in digital to find new and innovative ways to ...

Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

The IEC 62304 standard [1] specifies life cycle requirements for the development of medical software and software within medical devices. It is a standard that is harmonized between the European Union ...

Validate it? I just want to use it! Sound familiar? Most companies in the medical device industry understand and accept the need to validate software that is critical to the functioning of a medical ...