- Quality Assurance and Control Services
- ISO 9001:2015 and AS9100 Rev.D
- ISO 13485:2016 and 21 CFR 820
- Internal and External Audits
- Training for employees, internal auditors
- Qualification suppliers according ISO standards
- First Article Inspections – management, supporting
- Inspections of Manufacturing Processes
- Preparation of Quality Documentation
- Implementation of continual improvement processes
- Management of Change Management Process
- Implementation of FDA Regulations for Medical Devices
- Premarket Notification – 510(K) compilation
- Management and maintenance of all document control activities
- Management and tracking company calibration system
- Rail, Aerospace, Transportation, Manufacturing, Medical industries
Contact Us for assistance with your ISO / quality consulting needs.
The mission is to provide you with customized solutions to meet your specific business needs. The process is always flexible, with a focus on maximizing your return on investment. We’ll be happy to discuss your options.