Traceability, Risk Management and Responsive Supply Chain
for Medical Device, Biotechnology and Pharmaceutical OEMs
There is increasing global pressure on medical and life sciences OEMs from government, insurers and patients to make healthcare more accessible and affordable.
At the same time, emerging communications technology and advancement in bioscience are driving the introduction of revolutionary products.
In this environment with competing priorities, companies producing medical devices are looking ever more to their strategic outsourcing partners to help them provide new innovative, flexible solutions and reduce costs to their customers.
Of course, this innovation and cost reduction can’t come at the expense of the quality and traceability that’s so critical in medical applications.
Creation Technologies Helps Medical Device, Biotechnology and Pharmaceutical Equipment OEMs Fuel Business Growth with Proactive Design and Manufacturing Solutions that Meet Stringent Regulatory Requirements.
“First-Rate” Quality and Flexibility
“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. Creation Technologies is greatly appreciated.”
Chief Science Officer
Medical Device OEM Specializing in Dental Diagnostics
25+ Years in Medical Product Development and Manufacturing that Meets the Stringent Traceability and Quality Requirements of Medical Devices
Turnkey and Partial Product Design & Development
- Specific Regulatory and Quality Expertise for Medical Devices
- In Vitro Diagnostics, Biotechnology Instrumentation, EKG & EEG, Imaging, Diagnostics and Therapeutic Devices
- Optical, Fluidics, Mechanical, RF, Risk Assessment, Verification and Validation, Support for Clinical Trials
- Software from UI to Remote Diagnostics, Firmware, Mobile Apps
Rapid Prototyping and Accelerated Product Transfer
- Risk analysis and regulatory guidance for Class I, II and III medical devices
- ISO 13485 design control, documentation and Quality Management System standards
- Engineering prototyping for PCBAs and complete medical systems
- FDA Pre-Market Approvals
- Rapid Prototyping through Creation Express Services
Lean Manufacturing and Product Traceability
- ISO 13485-certified and FDA-registered business units
- Expertise in Leading-Edge Technology and Complex Systems
- Full Systems Integration and Test, including RF, ESS, HALT, HASS
- Fine-pitch BGAs, New Chipsets, DFM for Small Components
- Electromechanical Assembly Expertise
- Conformal Coating & Potting
- Clean Room Manufacturing
- Full component-level and product-level traceability and HIPPO data management
Direct Fulfillment & Logistics for Complex Systems
- Direct Order Fulfillment specifically designed for medical products
- Tailored Product Supply for just-in-time delivery and inventory management
- Global Logistics and Customs expertise
Product Lifecycle Management (PLM) and Sustaining Engineering
- Design for Regulatory, Design for Supply Chain and Risk Mitigation, Design for Manufacturing
- Design for Environment and RoHS Conversion
- EOL Management and Counterfeit Mitigation
24/7 Visibility through Creation's Vision Customer Portal
- Access to Critical Supply Chain, Operational and Quality Data through Creation’s Vision Customer Portal
For Medical OEMs, Creation Technologies' Regulatory and Quality Expertise, Supply Chain Agility and Product Traceability Differentiate Us from Other EMS Providers.
Quality & Regulatory Compliance and Leadership
If you need:
Outsourcing solutions that mitigate your risk and ensure you meet changing FDA and RoHS requirements
Creation Technologies provides:
Leading product quality, regulatory guidance and compliance, and FDA-validated systems
Get the peace of mind you require with Creation’s ISO 13485-certified and FDA-registered business units, design and manufacturing expertise in Class I, II and III medical devices including Pre-Market Approvals, and 21 CFR Part 11 -validated business systems.
Creation Technologies Certifications & Experience for Medical Devices
- ISO 13485 Certification for Design Controls, Manufacturing, Documentation, Quality Management System Standards
- ISO 9001, ISO 14001 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
NPI and Supply Chain Agility for Highly Complex Products
Improve Your 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).
Complex Supply Chain Design and Management
Manage your increasingly complex supply chain by leaving the management to us.
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.
Real-Time Access to Key Product and Supply Chain Data
And with Creation Technologies’ Vision Customer Portal, you’ll have 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!
Traceability and Counterfeit and IP Protection
If you need:
Confidence that your information is traceable and secure to protect your investment and brand
Creation Technologies provides:
Rigorous supply chain controls and secure operations
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.
Secure and Reliable Production Environments
Creation Technologies’ manufacturing facilities are ISO 13485-certified and FDA-registered. They are also ITAR- and CGD-registered in order to meet the needs of our customers in the highly regulated Defense and Security industries.
For all of Creation’s customers, this means your IP is protected through secure business systems and information technology, and segregated in the production environment through a cellular manufacturing model.
Experienced Teams Dedicated to Your Products
Creation’s Customer-Focused Team structure also provides you with a dedicated team experienced with medical devices. This approach:
-
Controls the number of people interacting with your products and information
-
Results in improved communication and collaboration
-
Extends your team with an outsourcing partner that understands your requirements, industry challenges and vernacular.
- Quality & Regulatory Compliance and Leadership
-
Quality & Regulatory Compliance and Leadership
If you need:
Outsourcing solutions that mitigate your risk and ensure you meet changing FDA and RoHS requirements
Creation Technologies provides:
Leading product quality, regulatory guidance and compliance, and FDA-validated systems
Get the peace of mind you require with Creation’s ISO 13485-certified and FDA-registered business units, design and manufacturing expertise in Class I, II and III medical devices including Pre-Market Approvals, and 21 CFR Part 11 -validated business systems.
Creation Technologies Certifications & Experience for Medical Devices
- ISO 13485 Certification for Design Controls, Manufacturing, Documentation, Quality Management System Standards
- ISO 9001, ISO 14001 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
- NPI & Supply Chain Agility
-
NPI and Supply Chain Agility for Highly Complex Products
Improve Your 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).
Complex Supply Chain Design and Management
Manage your increasingly complex supply chain by leaving the management to us.
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.
Real-Time Access to Key Product and Supply Chain Data
And with Creation Technologies’ Vision Customer Portal, you’ll have 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!
- Traceability and Counterfeit & IP Protection
-
Traceability and Counterfeit and IP Protection
If you need:
Confidence that your information is traceable and secure to protect your investment and brand
Creation Technologies provides:
Rigorous supply chain controls and secure operations
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.
Secure and Reliable Production Environments
Creation Technologies’ manufacturing facilities are ISO 13485-certified and FDA-registered. They are also ITAR- and CGD-registered in order to meet the needs of our customers in the highly regulated Defense and Security industries.
For all of Creation’s customers, this means your IP is protected through secure business systems and information technology, and segregated in the production environment through a cellular manufacturing model.
Experienced Teams Dedicated to Your Products
Creation’s Customer-Focused Team structure also provides you with a dedicated team experienced with medical devices. This approach:
-
Controls the number of people interacting with your products and information
-
Results in improved communication and collaboration
-
Extends your team with an outsourcing partner that understands your requirements, industry challenges and vernacular.
-
How are connected devices shaping the future of healthcare?
The billion-device, billion-dollar Internet of Things (IoT) holds the potential to dramatically transform healthcare.
Wirelessly connected medical devices increase patient mobility while giving healthcare professionals real-time access to patient data, throughout the hospital, and at the point of care.
Related Solutions
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