Process

We are proud of the strong product development process that we follow. The process is based on Design Excellence methodology i.e. DMADV2 of product development. We are ISO 9001 and ISO 13485 certified organization. We have set our processes in line with ISO 13485, MDD 93/42/EEC, and US FDA requirements.

The device under development is refined over a period of time with reviews carried out by independent reviewers, at each stage of product development. We lay a strong emphasis on worthiness and transparency of verification and validation data. We also follow ISO 14971, ISO 10993 and other product specific ISO standards during product development. We also follow ISO 11135 for sterilization process.

Design excellence comprises of 6 distinct stages.
     
 
Business Plan
Technical Design Inputs
Resource Identification
Resource Allocation
IP search
 
Transfer to Manufacturer
Market Launch
Post launch assessment
Data Archiving &
management
Post Market Surveillance
Patent Management
Concept selection
Project Plan
Design & Development
planning
Environmental, Health
& Safety Management
User Interface
Mock Modeling
Operations Planning
 
Protocol Development
Investigator Brochure
Regulatory Approval
Patient information
consent form
Investigator selection
Patient enrollment
Site Initiation
Trial monitoring
Data analysis
Report Writing
Integrate results
with product design team
Medical Interpretation
and final study report
Clinical literature
searches
 
Product design
Electronic System design
Product specification
Design Risk management
Manufacturing Risk
management
FEM analysis
Material selection
Vendor Selection
Regulatory Planning
 
Pilot Manufacturing
Packaging and Sealing
Stability studies
Electronic Device Assembly
EtO / Gamma Sterilization
Animal trial
Cadaver testing