MEDICAL DEVICE AND MEDTECH SERVICES
Boosting medtech and IVD innovation in a QMS framework
Your partner in every stage of the MD/IVD product lifecycle journey
Our dynamic medtech and IVD industry solutions, including self-care medical devices, are designed to support manufacturers and stakeholders throughout the entire product lifecycle. Our expertise lies in quality and regulatory affairs with a strong focus on regulatory strategy, design control expertise, technical documentation, and MDR and IVDR transition support. We deliver tailored QMS support according to regulatory frameworks (ISO 13485, 21 CFR part 820, MDSAP), high-end regulatory services with main RA pillars, and post-market surveillance. With years of experience, our team can drive new innovative companies to deliver new solutions, providing flexibility, cost-effectiveness, and a dedicated commitment to driving technological advances to improve human health.
Our services
Device Design and Development Support
MDR/IVDR Transition & Readiness Support
Quality Management System (QMS) support
Medical Device Regulatory Services
Post-Market Support in Medtech and IVD
Proficiency to guide you through medtech and IVD international standards
- We are globally present, covering different countries with our experts and partners, and committed to delivering successful and impactful outcomes.
- Our dedicated team’s deep understanding can help you with a strategic and lean approach to the world’s next-generation healthcare solutions.
- We provide hands-on experience across different types of devices (MD/IVD) and classes.
KEY FIGURES
40+
More than 40 projects handled in the last 3 years across different domains from quality to regulatory support.
4+
More than 4 projects involving innovative solutions in partnership with the European Institute of Innovation & Technology (EIT)
95%
Customer satisfaction rate: Reflecting our commitment to continuously ensuring and meeting customer expectations.
180%
Growing activities and services.
In the ever-evolving medical device industry, we provide tailored regulatory, scientific, and clinical solutions from development to post-approval for various devices, including self-care consumer health devices. Prioritizing patient well-being, we navigate complexities to ensure regulatory compliance and optimize your device’s commercial success.
Keval Bhoola
Self-Care Medical Device Manager (RNI), ProductLife Group
