OEM Components
DirectMed has been supplying components to the medical device industry for over 27 years. We are ISO 13485 certified and are well-equipped to manage the regulatory oversight that governs the medical device industry and its strict quality requirements. We have access to a global supply chain that allows us to provide Medical Device Manufacturers with thousands of first world quality OEM components on time, every time.
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Inventory and Supply Chain Relationship Management
We have spent almost three decades building and consolidating relationships with medical component manufacturers around the world. These deep relationships only come with time, familiarity and an affinity for cultural values, ethics, and shared common objectives. It is these relationships which enable DirectMed to assure the timely, accurate sourcing and fulfillment of your OEM components.
We offer an extensive inventory of samples because of our many design and development projects that require this accessibility and knowledge of the complex process. We also understand the challenges faced by our customers trying to offer the best quality at the best price possible. We have spent decades making sure our supply chain is highly reliable, and we are able to assure that the OEM components you order are a “perfect fit” for your medical device manufacturing needs.
Regulatory Compliance
DIRECTMED and all of its suppliers are certified to ISO-13485 standards and many with additional ISO certifications as well.
We offer complete access to quality compliance, regulatory information, and traceability for any of our products.
The components we offer have been verified to meet all relevant regulatory information, including, but not limited to:
- REACH
- RoHs
- ISO Compliances
- ISO 80369-3
- ISO 80369-4
- ISO 80369-5
- ISO 80369-6
- ISO 80369-7
- Conflict Mineral Compliance
- California Proposition 65
- 510K coverage for all IV Administration sets and Extension sets
Rest assured that if we can’t source it, chances are the part does not exist. That’s where our decades of experience working with customers on custom tooling and contract manufacturing projects come into play. We will work with you to provide an EXACT solution to your product needs.
Sample Inventory
Our comprehensive sample inventory reduces product development costs and lead times. Product engineers just request the stock items they need, and our dedicated staff sends them out the next day. We offer complete access to our product library which includes:
- Complete Regulatory information
- Detailed technical drawings
- Full material information including biocompatibility
- Tooling and design process validations
Rest assured that if we can’t source it, chances are the part does not exist. That’s where our decades of experience working with customers on custom tooling and contract manufacturing projects come into play. We will work with you to provide an EXACT solution to your product needs.
