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Regulatory and Quality

Turn regulatory requirements into forward-thinking products that mitigate your risk and differentiate your brand.

Get a holistic quality, validation and verification, and 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.

Download Creation Technologies’ Full Registrations and Quality Certifications

Navigating evolving regulatory requirements is one of the key challenges in new product development. Are you succeeding?

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, for products in even the most regulated of markets, like medical.

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 medical product development with confidence.

Learn More about Medical Product Development Here

Regulatory Guidance and Compliance

  • ISO 9001, ISO 13485, ISO 14001
  • ISO 62304, ISO 61010 and ISO 60601
  • ITAR registration
  • UL, CSA, TUV, FM, MET, ETL
  • CE marking, RoHS-compliance and other environmental regulations

Specific Medical Device Regulatory Expertise

  • ISO 9001, ISO 13485, ISO 14001
  • ISO 62304, ISO 61010 and ISO 60601
  • ITAR registration
  • UL, CSA, TUV, FM, MET, ETL
  • CE marking, RoHS-compliance and other environmental regulations

Creation Technologies can help you avoid devastating regulatory pitfalls.

Quality Management System and Quality Engineering

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 company, and 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 medical 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.
creation design services qms

Verification, 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
Rapid Engineering Prototyping through Creation Express Services and Value Engineering to prove out your design in a manufacturing environment.
verification and validation
+ Quality Engineering and QMS

Quality Management System and Quality Engineering

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 company, and 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 medical 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.
creation design services qms
+ Validation and Test Development

Verification, 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
Rapid Engineering Prototyping through Creation Express Services and Value Engineering to prove out your design in a manufacturing environment.
verification and validation

Need Help with a Project?

Product Developmnet and Engineering

Call toll free 877.734.7456…

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