Quality and Regulatory
Primo Medical Group is an ISO 13485:2016 compliant company. (Download certificates here: ISO 13485 2016). Our quality standards meet or exceed both ANSI/ASQ Z 1.4 and Military Standards and specifications, and we are also a registered manufacturer with the Office of Defense Trade Controls Compliance. Our long-established reputation is built upon our persistence to consistently meet or exceed the quality requirements and expectations of our customers. By maintaining continuous control over all aspects of our processes, we provide our customers with well-documented quality assurance.
Our quality control expertise is in the areas of:
- Customer Specific Quality Inspection Plans
- Customized Sampling Plans
- ANSI/ASQ z.1.4 and Military Standards and Specifications
- Geometric Tolerancing
- Supplier Management
- Statistical Process Controls
- Equipment Installation Qualification and Preventative Maintenance
- Corrective and Preventative Action Program
- Complaint Management
- State of the Art Inspection Equipment
- Keyence Digital Imaging Systems
- Programmable CMMs
- CAD Based Inspection
- Exceptional Level of Training
Other Quality System Services
- Process Validations
- Capability Analyses
- Special Validations: Sterilization, Packaging
- Gage R&R Studies
- Component Qualifications
- First Article Inspection
- Operational Qualification
- Performance Qualification
- Test Method Development and Validation
- Software Validation
- Compliance and Remediation Testing
- Gap Analyses
- Risk Management File Development
Contact us today to learn more about our Quality Systems and Services and how we can be your trusted partner in contract manufacturing and services.