We offer solutions in compliance with FDA's 21CFR820 and ISO13485 and cover a broad range of services:
Quality systems:
- Design control
- Management responsibilities
- Corrective and preventive actions system
- Complaint handling and failure investigation
- Post market surveillance
- Internal audits
- Development and implementation of standard operating procedures, including training programs to improve efficiency and promote compliance.
- Measurement and trending of quality systems and operations metrics
Quality engineering:
- Risk management per ISO14971
- Validation and verification testing including: biocompatibility per ISO10993, sterilization Validation per ISO11135/ISO11737, shelf life testing, packaging validation, etc.
- Non conforming material investigation and reporting
- Supplier management: procedures, reevaluations, audits and systems for continuous feedback.
- Sampling plans and statistical techniques implementation
Quality control:
- Receiving inspection for evaluating incoming product
- Inspection plans and procedures