Compliance & Certifications
Navigate global regulatory requirements with confidence. Our comprehensive compliance expertise ensures your products meet international standards and gain access to worldwide markets.
Global Compliance Expertise
Your Gateway to International Markets
Regulatory compliance is critical for accessing global markets and ensuring product safety. Our comprehensive compliance services help navigate complex regulatory landscapes while maintaining the highest quality standards. With over 25 years of experience in regulatory affairs, we understand the nuances of international standards and provide end-to-end support for certification processes. Our expertise spans medical devices, automotive components, electronics, and food contact applications, ensuring your products meet all applicable requirements for successful market entry.
Key Highlights
- Complete regulatory compliance support
- ISO 9001, 13485, and 16949 certifications
- FDA and MDR compliance expertise
- Environmental standards (RoHS, REACH)
- Global market access facilitation
- Risk mitigation strategies
- Continuous compliance monitoring
- Expert regulatory consultation
Additional Capabilities
Book a free technical consultation
Speak with a manufacturing engineer within 48 hours. Get rapid DFM insights, material guidance, and a clear path to production.
Measurable Business Benefits
Compliance Advantages
Proper compliance management delivers tangible business value through market access, risk reduction, and operational excellence. Our systematic approach to regulatory compliance ensures sustainable business growth and competitive advantage.
Global Market Access
Market AccessUnlock international markets through proper certification and regulatory compliance
Key Points:
- Certified for 50+ global markets
- Streamlined approval processes
- Regulatory pathway guidance
Risk Mitigation
Risk ManagementProactive compliance reduces liability and protects your business interests
Key Points:
- Legal compliance assurance
- Liability reduction
- Audit readiness
Quality Excellence
QualitySystematic quality management drives operational improvement and customer satisfaction
Key Points:
- ISO certified processes
- Continuous improvement
- Performance monitoring
Customer Confidence
Business ValueRecognized certifications build trust and credibility with customers and partners
Key Points:
- Third-party validation
- Brand reputation enhancement
- Competitive differentiation
Comprehensive Standards Coverage
Certification Portfolio
Our extensive certification portfolio ensures compliance with global standards across multiple industries and applications. Each certification is maintained through rigorous audit processes and continuous improvement.
| Property | Value | Tolerance | Description |
|---|---|---|---|
ISO 9001:2015(Certification) Quality ManagementAnnual surveillance | Active | Quality management system standard | |
ISO 13485:2016(Certification) MedicalAnnual surveillance | Active | Medical devices quality management | |
IATF 16949:2016(Certification) AutomotiveAnnual surveillance | Active | Automotive quality management | |
FDA Registration(Registration) MedicalBiennial inspection | Active | FDA medical device facility registration | |
CE Marking(Marking) European UnionProduct-specific | Authorized | European Conformity marking authority | |
UL Recognition(Recognition) SafetyAnnual follow-up | Active | UL component recognition program |
Compliance Design Guidelines
Design for Regulatory Success
Integrate compliance considerations from the earliest design stages to ensure smooth regulatory approval and market success. Our guidelines help avoid common compliance pitfalls and accelerate approval timelines.
Compliant Material Choices
Select materials that meet regulatory requirements for your target applications and markets
Key Tips:
- Use FDA-approved materials for food contact
- Select USP Class VI materials for medical devices
- Choose RoHS-compliant materials for electronics
- Consider biocompatibility requirements for medical applications
Design Documentation Requirements
Maintain comprehensive design documentation to support regulatory submissions
Key Tips:
- Document design inputs and requirements
- Maintain design history files
- Implement design controls per ISO 13485
- Conduct design reviews and validations
Risk-Based Design Approach
Integrate risk management throughout the design process per ISO 14971
Key Tips:
- Conduct hazard analysis and risk evaluation
- Implement risk control measures
- Monitor residual risks
- Maintain risk management files
Validation and Verification Planning
Plan testing and validation activities to demonstrate compliance with requirements
Key Tips:
- Define acceptance criteria early
- Plan validation protocols
- Consider statistical requirements
- Document testing procedures and results
Need Design Consultation?
Our design engineers can review your parts and provide recommendations for optimal manufacturability and cost reduction.