Your pharma-to-medical device journey
Pharma is heavily regulated – but medical devices according to MDR follow different rules. Instead of pharmacological proof of efficacy, the focus is on technical performance, clinical safety and ISO 13485-compliant quality management. BAYOOCARE accompanies you through this transition.
Our services for pharmaceutical companies
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Regulatory advice & approval
Tailor-made approval strategy for the MDR environment – with a focus on the differences to pharmaceutical approval. Technical documentation, risk analyses and communication with notified bodies.
QMS according to ISO 13485
Implementation or optimization of your QMS specifically for medical devices. Internal audits, supplier audits and training – even if a GMP system is already in place.
Clinical evaluation & trials
Planning and conducting clinical trials with a focus on technical performance and safety – instead of pharmacological proof of efficacy. Preparation of clinical evaluations and PMCF strategies.
Risk management & conformity assessment
Systematic risk management in accordance with ISO 14971: risk identification, assessment and minimization measures. Preparation and implementation of the conformity assessment for CE marking.
Post-Market Surveillance & Lifecycle
Development of PMS processes, creation of PSURs and vigilance activities. Change management and process optimization along the entire product life cycle.
Market access & strategic consulting
Market access strategies for the EU, CH, UK and USA, taking into account the special features of the medical device market. Advice on regulatory trends and country-specific requirements.
Project management & operational support
Project management for smooth development and approval processes. Resource planning, documentation support and coordination of all parties involved.
Training & education
Training on MDR/IVDR, ISO 13485, clinical evaluation and PMS for your teams – specially tailored to employees from the pharmaceutical sector who are new to the world of medical devices.
