Services

Our Design team will work with you to turn your concept and ideas into engineered solutions and working prototypes ready for development and eventual commercialization. We complete this step with an eye toward your needs, compliance with regulatory requirements, cost targets, and manufacturing process selection. We have over 50 years of medical device R&D experience, including nearly 60 issued patents, that we bring to your project

Capabilities:

• Concept development

• Formal engineering drawings

• 3D CAD and assembly models

• Material and supplier selection

• Manufacturing process expertise and selection

• Quick turn physical and digital prototyping

  • Using our in-house manufacturing capabilities

  • Or those of our partners when necessary

During the Development process, we will refine the design so that it meets all requirements and can be efficiently and cost-effectively produced. We will work with you to define the final requirements and user needs and plan those Design Control activities required to achieve regulatory compliance for the product launch. Using our manufacturing capabilities, we can make functional prototypes for use in refining the design. When the Development stage is complete, you will have a final documented design ready to transfer to manufacturing and verification testing.

Capabilities:

• Requirements gathering and documentation

• Physical creation of the final system focused on the user experience

• Compliance with domestic and international regulatory standards

• Product cost reduction and estimation

• Project Planning to include Design Control planning and document creation

Our Production group develops the processes required to make your device in R&D test quantities or in full-scale manufacturing volumes, even if we did not design or develop your product. Production is one of our core competencies and we specialize in providing production services to start-ups and small companies who may not get attention and service from a larger vendor. We can support your small design verification test or regulatory submission build using in-house production equivalent processes and we can scale those processes to support your commercial launch. We will help you address design for manufacturing issues, source equipment, tooling and fixtures, and complete all qualification and validation activities required. We will source all raw materials and manage those vendor relationships so that you don’t have to.

Capabilities:

• Process design, qualification, and validation

• Cost estimation and management of cost reduction efforts

• Design Transfer per regulatory requirements

• Provide pre-validated sterile packaging (pouches and blister packs) as well as validated ethylene oxide and gamma sterilization cycles.

• Vendor selection and Supplier management

• Raw material sourcing and inventorying

• See our Technologies for a list of our in-house production process capabilities

The Regulatory group provides support for commercial approval and/or clearance for human use of the device in various marketplaces (both domestic and international). We can also work with outside resources to ensure a smooth transition of design and development documentation to regulatory submissions (510(k), PMA, CE Mark, etc.). The group has extensive experience in both regulatory submissions for achieving commercial release as well as general regulatory communications (via the Q-submission process with the FDA).

Capabilities:

• U.S. regulatory strategies

• International regulatory strategies

• Prepare and manage regulatory submittals

Our Quality Assurance and Compliance group provides support for managing all quality aspects of your project from feasibility to commercialization and post-market surveillance. We can host your quality system so that you remain compliant with applicable regulations and you can concentrate on other aspects of your business. We will generate and support a client-centric quality management system for you We can also provide a US address for FDA registration until such time as you are ready to support your own operations.

Capabilities:

• QMS development and implementation

• QMS Hosting

• Ongoing QMS management

• Project management support

• Provide US address for FDA registration

As a start-up, your resources are constrained; we get that. That’s why we can inventory finished goods and fulfill orders for you so that you can concentrate on growing your business. We will dedicate warehouse space for your product for pick and pack operations and ship your product directly to your customer / distributor per your instructions.

Capabilities:

• Finished Goods inventory hosting and management

• Order processing and management

• Order fulfillment SOP development and execution