The global medical device regulatory space is becoming increasingly complex, making a well defined and researched regulatory strategy vital for medical device and in-vitro diagnostic (IVD) companies. With many changes...
Transition planning is critical As the March 2019 deadline for ISO 13485:2016 is fast approaching, now is the time to start actively planning for the transition. When planning for the...
Selling any product into the European market can be simplified if a manufacturer can show that it complies with appropriate regulations. For medical device manufacturers, this compliance is vital. Regulatory...
The development of a sound regulatory strategy is an essential starting point for medical device and in-vitro diagnostics (IVD) manufacturers. Regulatory strategy planning is critical to ensure compliance with all...
In September 2012, the European Commission announced a proposal for regulation changes to medical devices and in vitro diagnostic medical devices. According to Medtech Insight News these regulations are likely...
In house Class 4 IVDs – new manufacturer’s evidence accepted Goods new for laboratories that manufacture Class 4 in-house IVDs. A new conformity assessment procedure has been introduced. The following...