Medical & Life Sciences

Medical & Life Sciences

Innovation with the Patient in Mind

TRACEABILITY, RISK MANAGEMENT AND RESPONSIVE SUPPLY CHAIN —

Advanced Manufacturing Technologies for Class I, II & III Medical Devices, Biotechnology and Pharmaceutical OEMs

With the global mandate to make healthcare more accessible, affordable and wirelessly connected, medical and life sciences OEMs look to their strategic outsourcing partners more than ever to co-create revolutionary advancements in technology that lower costs and improve outcomes — all without compromising quality and traceability.

As the Internet of Things (IoT) continues to drive astounding breakthroughs in healthcare, patients are becoming more mobile, aware and self-sufficient in their care, while professionals enjoy easier access to data.

Creation delivers proactive design and manufacturing innovation across these healthcare fronts, and more, all while meeting stringent regulatory requirements for ensuring product accuracy and patient safety.

Get the Right Strategic Partner for your OEMs

“Creation’s level of expertise in manufacturing and quality systems is first rate.

They are wonderful people to work with from the assembly personnel, to the team engineers, our Customer-Focused Team Leader to the plant manager and executive management. Everyone has been very flexible in working with our company as we navigate these changing times.”
Chief Science Officer
Medical Device OEM Specializing in Dental Diagnostics

Look to creation for the solutions you need

Turnkey and Partial Product Design & Development

Rapid Prototyping & Accelerated Product Transfer

Lean Manufacturing and Product Traceability

Direct Fulfillment and Logistics for Complex Systems

Product Lifecycle Management (PLM) and Sustaining Engineering

24/7 Visibility through Creation’s Vision Customer Portal

In-House Testing Development and Detection Dianostics

  • Test Design and Development
  • Failure and Reliability Analysis
  • Complex Test Programs, including RF and ESS for Ruggedized Products
  • In-House ISO 17025-Certified Testing
  • FDA Testing for Submission and Ongoing Audit and Reporting
  • Clean Room Manufacturing and Testing
  • Testing Fixture Development

Why Partner with Creation for Life Sciences?

NPI & Supply Chain Agility for Highly Complex Products

Accelerate Speed-to-Market

Fast-track design and functionality validation and get new programs to market quickly with Creation’s expertise in program management and quality and regulatory approvals, and proven methodologies for product transfer and new product introduction (NPI).

Optimize Complex Supply Chain

Creation’s strategic sourcing, commodity management, product cost engineering and international procurement office teams have decades of expertise building and managing responsive, global supply chains proven to produce product on budget and on schedule.

Enjoy Greater Information Access & Visibility

Creation Technologies’ Vision Customer Portal delivers real-time access to order confirmations, tracking info, WIP reporting and excess materials.  Learn what it’s like to never again have to ask for an open order report!

The Results

  • Increased speed-to-market and time-to-volume
  • Lean product design, a proven product transfer process and a responsive supply chain
  • Master your increasingly complex supply chain by leaving the management to us.

Traceability and Counterfeit & IP Protection

Protect & Sharpen Your Competitive Edge

Strong relationships with Creation’s supply base partners, rigorous materials handling processes and our Vision manufacturing execution system (MES) ensure product traceability down to the component level, counterfeit prevention, and enable asset tracking and serialization.

Trust Our Secure and Reliable Production Environments

Creation protects your IP through secure business systems and information technology that is segregated within the production environment through a cellular manufacturing model.

Rely on Expert Teams Dedicated to Your Products

Creation’s Customer-Focused Team structure also provides you with a dedicated team experienced with medical devices that understands your industry challenges and vernacular.

The Results

  • Confidence that your information is traceable and secure
  • Protection of your brand investment
  • Rigorous supply chain controls and secure operations
  • Controlled access to your products and information
  • Improved communication and collaboration

Quality, Regulatory Compliance & Leadership

Collaborate with Expert Business Units

Creation’s ISO 13485:2016-certified and FDA-registered business units provide design and manufacturing expertise in Class I, II and III Medical Devices, including Pre-Market Approvals and 21 CFR Part 11-validated business systems.

THE RESULTS:

  • Outsourcing solutions that mitigate your risk and ensure you meet changing FDA and RoHS requirements
  • Leading product quality, regulatory guidance and compliance, and FDA-validated systems

Certifications

ISO 13485:2016 Certification for Design Controls, Manufacturing, Documentation, & Quality Management System Standards

Standards ISO 9001:2015, ISO 14001:2015 Certifications

FDA-Registered Facilities and Familiarity with End-Customer FDA Audits

Manufacturing Execution System Validated to 21 CFR Part 11

Class I, II and III Expertise and Regulatory Controls

PFMEAs, Verification and Validation Expertise

IPC RoHS Compliance and Environmental Compliance Services

IP Protection through Business Systems Validated for International Traffic in Arms (ITAR) Registration with US Department of State and Canadian Controlled Goods Directorate (CGD)

UL, CSA, TUV, CE, FM, MET, ETL, IEC, IECEx, JPAL

Contact Us

Interested in becoming a supplier? Visit our supplier page.

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