3R LifeScience
3R LifeScience GmbH supports medical technology companies through consulting, interim management, and project management, leveraging extensive experience in product development, regulatory compliance, quality management, clinical research, and MDR transition. The company aims to help clients develop innovative medical products efficiently, achieve MDR and other regulatory compliance, and bring products successfully to market. They also assist in risk management, due diligence, and strategic development to ensure sustainable success in the MedTech industry.
Industries
Nr. of Employees
small (1-50)
3R LifeScience
Products
White paper: Risk Management
Practical guidance on implementing medical device risk management and organisational measures to maintain traceable risk documentation.
White paper: Requirements Management
Recommendations for establishing requirements-management processes to reduce development risk and improve specification control.
White paper: Process Validation
Overview of process validation requirements for medical device production and implementation recommendations for QMS evidence.
White paper: MDD to MDR transition
Practical guidance and checklists for planning regulatory transition activities from legacy directives to MDR 2017/745.
White paper: Quality Management
Recommendations for establishing and operating an effective QMS tailored to medical device organisations and audit-readiness considerations.
Case study: Complex medical device product development
Case study describing project recovery and end-to-end product development for a complex extracorporeal cardiac support system, covering project rescue, V&V, manufacturing transfer and regulatory submission activities.
White paper: Risk Management
Practical guidance on implementing medical device risk management and organisational measures to maintain traceable risk documentation.
White paper: Requirements Management
Recommendations for establishing requirements-management processes to reduce development risk and improve specification control.
White paper: Process Validation
Overview of process validation requirements for medical device production and implementation recommendations for QMS evidence.
White paper: MDD to MDR transition
Practical guidance and checklists for planning regulatory transition activities from legacy directives to MDR 2017/745.
White paper: Quality Management
Recommendations for establishing and operating an effective QMS tailored to medical device organisations and audit-readiness considerations.
Case study: Complex medical device product development
Case study describing project recovery and end-to-end product development for a complex extracorporeal cardiac support system, covering project rescue, V&V, manufacturing transfer and regulatory submission activities.
Services
End-to-end consulting covering feasibility, requirements management, coordination with external development partners, V&V planning and transfer to production for medical devices.
QMS design, gap analyses versus harmonised standards, MDR transition planning, clinical evaluation support and technical documentation management.
Support for production planning, supplier selection, manufacturing transfer, process validation planning and contract negotiation for manufacturing and logistics.
Planning and execution support for PMS systems, vigilance and PMCF activities to capture clinical and safety data after product launch and integrate findings into QMS and risk management.
Preparation of technical documentation and strategies for CE marking, communication with notified bodies and regulatory authorities, and registration strategies for select international markets including FDA preparedness.
Independent technical due diligence for investors and partners, including document review, interviews with technical teams, supplier assessment and market/competitor analysis to inform investment and integration decisions.
End-to-end consulting covering feasibility, requirements management, coordination with external development partners, V&V planning and transfer to production for medical devices.
QMS design, gap analyses versus harmonised standards, MDR transition planning, clinical evaluation support and technical documentation management.
Support for production planning, supplier selection, manufacturing transfer, process validation planning and contract negotiation for manufacturing and logistics.
Planning and execution support for PMS systems, vigilance and PMCF activities to capture clinical and safety data after product launch and integrate findings into QMS and risk management.
Preparation of technical documentation and strategies for CE marking, communication with notified bodies and regulatory authorities, and registration strategies for select international markets including FDA preparedness.
Independent technical due diligence for investors and partners, including document review, interviews with technical teams, supplier assessment and market/competitor analysis to inform investment and integration decisions.
Expertise Areas
- Medical device regulatory compliance and MDR transition planning
- Quality management systems and ISO 13485 implementation
- Risk management for medical devices (ISO 14971 methodology)
- Product development and systems engineering for complex devices
Key Technologies
- Risk management methodology (ISO 14971)
- Gap analysis for harmonised standards and GSPR mapping
- EN ISO 13485-based QMS frameworks
- PMS and PMCF study methodologies
News & Updates
Evaluation and setup of processes for CE marking and product registration of medical devices, including process optimization and interface integration.
Management and restructuring of a complex development project for a cardiac support system, ensuring compliance, timeline, and budget.
Providing interim management and strategic support for a start-up in ophthalmology, including certification strategy and funding.
Development of a business plan and investor search for a start-up with innovative inhalation technology.
Evaluation and setup of processes for CE marking and product registration of medical devices, including process optimization and interface integration.
Management and restructuring of a complex development project for a cardiac support system, ensuring compliance, timeline, and budget.
Providing interim management and strategic support for a start-up in ophthalmology, including certification strategy and funding.
Development of a business plan and investor search for a start-up with innovative inhalation technology.