How We Help
Where are you in the medical device product development lifecycle?
An understanding of the complex clinical and regulatory requirements early in the product lifecycle could ensure you gain the competitive advantage needed to bring your product to market.
Consolidated clinical and regulatory planning will assist you in maximizing resources and reducing the risk of costly redevelopments later in the lifecycle.
Select a segment below that represents where your product is in the product lifecycle to help you identify the considerations you should look into.
Phase 1
Concept
Initial evaluation of possible development of commercial product
How Rico Solutions can help you
Training
Compliance Navigator
Business and technical standards
Phase 2
Planning
Definition of design input based on customer needs and technical requirements
How Rico Solutions can help you
QMS ISO 13485
Business and technical standards
MDSAP
Compliance navigator
Training
QMS ISO 13485 pre-assessment
Phase 3
Design
Development of product design and of manufacturing process, verification and validation
How Rico Solutions can help you
QMS ISO 13485
Business and technical standards
MDSAP
Compliance navigator
Training
QMS ISO 13485 pre-assessment
Phase 4
Validation
Final validation of manufacturing process and preparation for product introduction
How Rico Solutions can help you
EU CE marking and UKCA marking
Business and technical standards
Training
QMS ISO 13485
MDSAP
Compliance navigator
Global market access and certification
Phase 5
Launch
Product launch
How Rico Solutions can help you
EU CE marking
Business and technical standards
Training
QMS ISO 13485
MDSAP
Compliance navigator
Global market access and certification
In-Country Representation
Phase 6
Post Market
Post market surveillance
How Rico Solutions can help you
Global market access
Business and technical standards
Training
QMS ISO 13485
Global market access and certification
Compliance navigator
Concept
Initial evaluation of possible development of commercial product
1
ConceptInitial evaluation of possible development of commercial product
Is it a medical device?
Intended use
Initial risk analysis
Product definition and intellectual property
Commercial plan
Potential markets and routes
Draft regulatory strategy
Personnel/resource requirements
How Rico Solutions can Help You
Definition of design input based on customer needs and technical requirements
Final validation of manufacturing process and preparation for product introduction
Development of product design and of manufacturing process, verification and validation
Product launch
Post market surveillance
