USA – MedCon: Consider the device risk management file a ‘living document’
Device manufacturers need to keep their risk documentation up to date throughout the total product life cycle by monitoring production and post-production information, according...
USA – FDA issues draft guidance on decentralized clinical trials
In a newly released draft guidance, the US Food and Drug Administration (FDA) is proposing recommendations on conducting decentralized clinical trials (DCTs) of drugs,...
International – Diabète : un pansement intelligent pour soigner et cicatriser les plaies chroniques
Les plaies chroniques dites « non cicatrisantes » concernent des dizaines de millions de personnes dans le monde. Ainsi, de 15 % à 25 % des patients diabétiques...
Europe – Team-NB : Best Practice Guidance for the Submission of Technical Documentation under...
This best practice guidance document has been developed by members of Team NB who have reviewed the best practice guidance documents submitted by individual...
UK – Medical devices – extended acceptance of CE marked medical devices on the...
A statutory instrument has been laid in Parliament, which will enable an extended timeframe for acceptance of CE marked medical devices on the Great...
Europe – Intellectual property: harmonised EU patent rules boost innovation, investment and competitiveness in...
Today, the Commission has proposed new rules to help companies, especially small and medium-sized companies (SMEs), make the most of their inventions, leverage new...
