We provide expert guidance and solutions aligned with FDA 21 CFR Part 820 and ISO 13485 standards, covering a wide range of quality system and engineering needs:
Quality systems:
Design control
Management responsibilities
Corrective and preventive actions system
Complaint handling and failure investigation
Post-market surveillance programs
Internal audits planning and execution
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 ISO 14971
Validation and verification testing including: biocompatibility per ISO 10993, sterilization Validation per ISO 11135 / ISO 11737, shelf life testing, packaging validation, etc.
Nonconforming 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