Comprehensive medtech support in medical and in-vitro diagnostic devices

Embarking on a journey to develop medical devices demands expertise at every step. At PLG, we aim to provide you with early-stage research and development support through regulatory compliance and safety assessments in all main categories and classes of medical and IVD devices, including drug-device delivery systems, combination products, innovative supported software solutions, digital therapeutics, medical device software, substance-based devices, and self-care medical devices. We have experience creating complete technical documentation per MDR requirements (device description, classification, GSPR, risk management, and usability study). In the main framework of ISO 13485, we can support medical device software management, technical documentation, biological and clinical evaluations, and clinical investigation setups. Our commitment is to ensure the highest standards throughout the development process. 

Exceptional expertise in MDR/IVDR requirements handling

– We provide comprehensive support across crucial aspects, including regulatory requirements (MDR /IVDR) and harmonized and applicable standards (considering EU and non-EU). 

– With a deep understanding of regulations, we ensure your product meets all compliance and legal requirements. 

– Our support through multiple projects gives us the experience to help you in clinical evaluation, risk management usability assessments, and biocompatibility testing. 

– We have successfully assisted hundreds of clients, ensuring product readiness for global markets. 

KEY FIGURES

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Innovative projects support from the early design stage.