New changes mean new challenges, but global harmonization could make things easier for device manufacturers in the long run.
Audits for medical device companies and other organizations in the medtech space used to be primarily in person. However, the pandemic magnified flaws in the global regulatory process. A shift to remote audits may be the key to interorganizational and international regulatory harmonization moving forward.
The pandemic is helping realize the potential of ISO IDMP data standards in relation to adverse event reporting, electronic prescribing and medicines control in the supply chain.
The center intends to facilitate partnerships, exchange knowledge and promote innovative regulatory approaches.
Whatever the short- and longer-term fallout of COVID-19, organizations will need to come back fighting—with new tools at their disposal and ready to raise their game.
For too long this industry has lagged the pharma sector in terms of using data analytics to predict market trends. It’s time to change that.
Drop the checkbox mentality and embrace accountability and understanding.
The total value of deals for 2019 exceeds $30 billion.
This new pathway is a considerable change for the medical device industry.