Start-Up Program for MedTech Manufacturers
From concept to compliant market launch in one integrated programme.
From concept to compliant market launch, in one integrated programme
Choose your starting point and follow a structured pathway through planning, development and demonstration of conformity, with QMS implementation and preparation for applicable product conformity assessment and system certification coordinated throughout the programme.
Concept Studio
OptionalFor early-stage ideas with no defined solution yet. Concept development and prototyping through our Concept Studio.
Explore Concept StudioDesign & Regulatory Readiness Review
For companies with defined concepts, a review of design direction against applicable regulatory requirements to help establish the development roadmap.
Integrated Roadmap
Unique plan aligning regulatory strategy, development, QMS, resources, suppliers and production readiness.
Development
Design and development, prototyping, risk management, verification and validation, pre-clinical and clinical evaluation, technical documentation.
Transfer to Production
Design transfer, process definition, equipment and facility readiness, process validation, supplier qualification, training.
Product & Market Launch
Product Launch
Controlled production, manufacturer-approved product configuration and release readiness.
Market Launch
Placing on the market, customer delivery, post-market start.
Product Life
Change management, configuration management, post-market activities and regulatory updates.
QMS Build & Implementation
Establish QMS framework, processes and responsibilities
Document, implement and train
Internal audit & management review
System effectiveness and continual improvement
Certifications (Product and QMS)
Conformity Assessment (CE Marking)
QMS Certification (ISO 13485)