The saying "an ounce of prevention is worth a pound of cure" is especially applicable when talking a...
Your regulatory strategy determines whether your 510(k) submission clears the FDA or dies on the vin...
The importance of preparing high-quality regulatory documents should never be underestimated. Low qu...
Increasing the efficiency of your Quality Management System (QMS) should be a no-brainer. When you i...
In an increasingly connected world, more countries look to protect their citizens through the develo...
The EU Medical Device Regulation (EU MDR) requires more than a few new SOPs. A profound overhaul of ...
The transition from EU MDD (2007) to EU MDR (2017) has included an increase in expectations for medi...
Risk management has been getting a great deal of attention in the medical device industry recently, ...
Is your business challenged by a complex and ever changing global regulatory environment? Medpoint c...