regulatory and quality
TURN REGULATORY REQUIREMENTS INTO FORWARD-THINKING PRODUCTS THAT MITIGATE YOUR RISK AND DIFFERENTIATE YOUR BRAND.
Get holistic quality, validation, and verification as well as regulatory strategy from the outset that ensures your products are safe, reliable and compliant with your market needs.
Address regulatory considerations – such as FDA, CE, RoHS and Conflict Minerals legislation – as early as the Planning and Requirements phase of product development. And meet design standards in the most cost-effective manner.
Creation Technologies can help you avoid devastating regulatory pitfalls.
Quality Engineering and QMS
Creation Technologies has a Quality Management System you’ll love.
Both the products we design for you, and Creation’s Quality Management System (QMS), stand up to the rigor of FDA and other agency audits, registrar audits, our customers’ audits and your customers’ audits.
Creation is a full-service EMS provider, and for over two decades, we’ve passed thousands of audits that span Creation Design Services’ product design and development process, as well as our manufacturing processes in all Creation manufacturing business units around the world.
We apply our quality expertise gained from the rigor of life sciences product development to all of our customers’ industries, in both design and critical production environments.
- Design Failure Modes and Effects Analysis (DFMEA)
- Process Failure Modes and Effects Analysis (PFMEA)
- Regulatory and production documentation including Manufacturing Quality Plans, quality manuals, etc.
VALIDATION AND TEST DEVELOPMENT
Validate your product development experience.
Ensure your design incorporates every technical and user requirement, then ensure your new product actually functions like it’s supposed to.
- Verification and Validation
- System, software and process validation
- Session-based testing
- Requirements tracing and testing
- Regression testing
- Test design and development for production
Benefit from Rapid Engineering Prototyping through Creation Express Services and Value Engineering to prove out your design in a manufacturing environment.
Download Creation Technologies’ Full Registrations and Quality Certifications
Regulatory Guidance and Compliance Services
In-house quality and regulatory affairs professionals support your project through FDA 510(k) or PMA submissions while working closely with your team.
Throughout the development process, Creation will help you navigate regulatory hurdles to obtain the approvals, clearances and documentation you require, including products that serve even the most regulated of markets, such as life sciences.
Implement or upgrade your own Quality Management System (QMS) and obtain agency certifications with a customized regulatory strategy and action plan.
Many of Creation’s Design Services customers even opt to use Creation’s QMS for product development because of its strength and scope.
Outsource your life sciences product development with confidence.
Regulatory Guidance and Compliance
- ISO 9001:2015, ISO 13485:2016, ISO 14971
- IEC 62304, IEC 61010 and IEC 60601
- ITAR registration
- UL, CSA, TUV, FM, MET, ETL
- CE marking, RoHS-compliance and other environmental regulations
Specific Life Sciences Device Regulatory Expertise
- ISO 9001:2015, ISO 13485:2016, ISO 14971
- IEC 62304, IEC 61010 and IEC 60601
- ITAR registration
- UL, CSA, TUV, FM, MET, ETL
- CE marking, RoHS-compliance and other environmental regulations
