To be, or not to be?
Identify the intended purpose of your innovation and define its uses. Our experts will check if your innovation is a Borderline Medical Device or just another non-medical product!
If your Innovation is a Medical Device, then we NEED to TALK!
A Regulatory strategy will create a pathway to protect your innovation with complete compliance with regulatory requirements.
Is your innovation a Medical Product in the EU/USA?
Are you sure?
Let our Experts confirm it for you!
Medical Regulations around the world have different interpretation for different medical products. Sometimes an algorithm could be considered as a Medical Device and at times a wearable device might be a wellness product!
Do not worry, Our experts are right here to bring a solution.
Rest of World regulatory and quality compliance expertise is provided by our parent company, Global Regulatory Services (GRS).
Mastering TPLC for Medical Softwares
The Total Product Life Cycle (TPLC) encompasses all phases of a medical device's life, from initial concept through post-market surveillance.
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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.
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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.
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