Product Development

Our product development is based on the following standards:

ISO 13485
FDA / cGMP requirements (21CFR 820) for medical devices
IEC 62366 Medical devices – Application of usability engineering to medical devices
ANSI/AAMI HE75 Human factors engineering – Design of medical devices
ISO 14971 Medical devices — Application of risk management to medical devices

Analysis Phase

Tasks/Analysis:

Discuss user needs with our customer and patients
Conceptualize a first product concept
Assess technical feasibility

Deliverables:

Draft a user needs analysis
Present initial prototype/design mock ups

Concept Phase

Tasks/Analysis:

Prepare the technical file
Define the regulatory pathway with our customer
Plan development, quality, and verification needs
Determine user and system requirements
Perform handling studies with product mock ups
Perform risk assessment at application level

Deliverables:

Present user and system requirements
Report on handling study with mock ups
Project planning documentation
Regulatory concept
Application level risk assessment

Definition Phase

Tasks/Analysis:

Obtain sub-system requirements
Refine the packaging concept
Perform risk assessment at system level
Develop first user interface

Deliverables:

Requirements for: mechanical, electronic, software, user interface, packaging, & labeling
System-level risk assessment
User interface mock ups (paper & software-based)

Development Phase

Tasks/Analysis:

Develop the mechanical, electronic and software sub-systems
Manufacture components, including sterile packaging
Verify the components
Assemble functional prototypes and perform first verification tests
Develop user documentation
Perform design and process risk assessment
Perform DQ, IQ and OQ of the production facilities

Deliverables:

Design description (mechanics, electronics, and software)
First manufactured components
Production facilities qualification
Design and process-level risk assessment
Unit-level tests

Design Transfer Phase

Tasks/Analysis:

Perform PQ and process validation
Perform design verification
Validate the design in handling studies with patients
Clinical validation (if necessary)
Finalize the risk management file
Establish device production
CE mark, support FDA filing for device

Deliverables:

Performance qualification (PQ)
Design verification and validation
Handling studies report with zero-series devices
Risk management report
CE marking, support materials for FDA filing

Product Support

Maintain production facilities with our network of suppliers
Offer device related product support
Periodically perform market surveillance
Periodically reevaluate the risk management file