Medical device 510(k) premarket notifications: sometimes slow and steady wins the race
As any medical device manufacturer knows, obtaining 510(k) clearance can represent a significant milestone in the product development journey. It can also be perceived as a major...
Medical device 510(k) premarket notifications: sometimes slow and steady wins the race
As any medical device manufacturer knows, obtaining 510(k) clearance can represent a significant milestone in the product development journey. It can also be perceived as a major...
How to sharpen up FDA medical device submissions and meetings
When medical device companies make an application or submission to the Food and Drug Administration (FDA) a lot of...
Five common questions about taskforces for PPP active substance renewals
With active substance renewals generally happening every ten years in the EU, the regulatory landscape can shift...
TSG strengthens ecotoxicology expertise with the appointment of Jennifer Duncan
TSG welcomes Jennifer Duncan, former Regulator at the UK Pesticide Safety Directorate (now CRD). With 20 years’...
Renewal of authorisation for plant protection products: three ways to help it run smoothly
EU authorisation of an active substance (AS) for PPP applications generally expires after ten years. Well in advance of...
Putting FDA regulatory strategy at the heart of medical device development
Laurie Clarke recently joined TSG Consulting to head up our medical device regulatory practice. Having formerly worked...
Professionals
Our regulatory specialists and scientists address all aspects of product registration and ongoing compliance. Read more about the individuals who make up our multi-disciplinary teams.
