Realization & Manufacturing

 

Design Through Manufacturing

Backed by the extensive experience of SteriPack Group’s manufacturing capabilities, we are able to offer a range of services to support the transition from design development through to manufacture.

Built on experience of getting a wide range of medical devices to market, along with complementary experience from industrial and consumer markets, we can support you with activities including supply chain sourcing, process development, design for assembly, design verification, clinical trial builds and pilot manufacturing. 

As well as providing a seamless interface with our Group’s contract manufacturing services, our support also applies when transferring to manufacture at our clients’ own manufacturing facilities, or with their chosen manufacturing partners.

Supply Chain Partner Management

We maintain a network of approved partners and suppliers, including those with ISO13485 accreditation. This allows us, on our clients’ behalf, to help select suppliers who best match the requirements of the individual project and client needs and manage these through the design development and manufacturing project.

Design for Manufacturing and Assembly

We have extensive experience delivering successful products through to manufacture. In the early stages of a project this experience is used to assess technical feasibility and guide concepts to meet cost and manufacturing objectives. In the later stages of a project, we have particular experience in designing parts for injection molding and metal fabrication processes. We provide all required manufacturing documentation including tolerance analysis and FMEA, delivering a final design data pack, ready for transfer to manufacture and launch of your product.

Test and Design Verification

We can support design transfer through our capabilities in design and product testing.  Our facilities include a range of equipment and processes to provide metrology, custom and IEC mechanical testing, environmental testing and ESD testing.

Small Batch Manufacturing

We have experience in supporting clients with small batch manufacture for product testing, clinical trials and manufacturing ramp-up.

We combine an established network of suppliers and manufacturing partners with our in-house facilities and processes, set up to your specific project requirements. Where appropriate, we can integrate expertise from our Group manufacturing centers to deliver controlled product assembly and test, conforming to quality standards including ISO13485.

Packaging and Sterilization

The team has extensive experience in the design, Human Factors testing and manufacture of packaging, labelling and kitting solutions, including, where appropriate management of the sterilization process, from design to validation.

Transfer to Manufacturing

With three manufacturing sites in US, Poland and Malaysia, SteriPack offers contract manufacturing solutions to our medical clients.  For clients with their own manufacturing capabilities, or with established manufacturing partners, our design and product development experience, enhanced by the wider SteriPack team’s manufacturing expertise, ensures smooth transfer from design to manufacture.

 

 

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HS Design, Inc. Headquarters
906 Mt. Kemble Ave
Morristown, NJ 07960

7097 Colorado Blvd.
Frederick, CO 80530-0237