From idea to Commercialisation!
Create a pathway to protect your innovation with complete compliance with regulatory requirements.
A well thought regulatory strategy enhances your production, business development and marketing plans.
Regulatory First Responders for your medical device.
We act as your EU AR / PRRC and represent your innovation to the European Commission!
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Planning to enter the EU/USA?
Not sure about market entry requirements?
Worried about MDR/USFDA requirements?
We are here for you!
We have a list of ongoing and routine services through which we help our clients with complete regulatory compliance.
Check our wide offerings for IVD:
Rest of World regulatory and quality compliance expertise is provided by our parent company, Global Regulatory Services (GRS).
MDCG 2014-15 Guidance on Clinical Investigations
Provides guidance on the publication of clinical investigation reports and their summaries in the absence of the EUDAMED database.
2.12.2024
Celebrating Three Decades of Excellence: Platform94’s Inspiring Journey from GTC
As Platform94 celebrates an impressive 30 years of service, we are honoured to reflect on their remarkable transformation.
18.11.2024
Internationalising MedTech Innovation
Don’t miss this chance to gain critical insights from industry experts with decades of experience navigating the complexities of MedTech international
11.11.2024