Quality Incubator Support Services

Life Science Outsourcing’s Quality Incubator Support offers an integrated, turnkey manufacturing facility equipped with office space, cleanrooms and experienced manufacturing professionals for startup medical device companies.

Quality Incubator Support Expertise

Quality Incubator Support clients can confidently outsource all or portions of the engineering, supply chain management, clinical builds, warehousing, product manufacturing, sterilization, testing, validations, and final distribution of devices to Life Science Outsourcing. Our 56,000 square foot fully functional facility located in Brea, California, allows us to provide comprehensive solutions that foster cost and resource savings, flexibility, and superior quality advantages gained by having all services in one central location.

Our services are supported by seasoned professionals who assist with FDA/ ISO audits to obtain 510K or CE Marking. Quality Incubator Support clients can operate under the Life Science Outsourcing quality management umbrella while developing an abbreviated quality system, and clients have complete access to DHR and DMR at all times. Our team can order, receive, and inspect parts from qualified vendors, ready to be used by the client team or our trained technicians dedicated to your project.

Individualized Services

Typically, clients will fall under one of the following categories with Option 1 being the dominant choice.

Option 1

  • Client: has / will register as the manufacturer of the record (OEM)
  • LSO: is registered as the contract manufacturer

Option 2

  • Client: has / will register as Specification Provider.
  • LSO: will register as the manufacturer of the record (OEM)

Option 3

  • Client: is not registered; diagnostic industry or is a medical device exporter
  • LSO: is registered as the contract manufacturer

Quality Incubator Support in Action

To better illustrate the benefits and process of Quality Incubator Support services, here’s a hypothetical engagement:

[ABC Medical] is a startup medical device company with three employees designing a product that will be used in the general surgery space to improve surgical outcomes and patient safety. So far, the principals have been working from their homes in different cities, collaborating via email, conference calls, or face-to-face meetings.

They have used their personal savings to fund the project and have made preliminary prototypes for proof of concept. Later they have proven that the concept is sound and have raised small amounts of seed money with a promise for a second round of financing. These monies will be appropriated only if they can meet the product’s functional requirements or receive 510k approval. ABC Medical has limited cash and wants to get to the market as fast as possible so they can receive funding as planned with minimal dilution.

Equally important, they also have to adhere to FDA / ISO requirements, with full traceability for their design and testing files. This portion of their documentation will be submitted later with their 510K / CE Mark application. ABC Medical eventually has to be registered as a “Manufacturer of record” and have an address for regulatory purposes. With this address, the auditors expect to find the company’s competent authority who can discuss quality system documents including DMR, DHR, training, CAPA, RGA, and failure investigation, to name just a few.

Initially, Life Science Outsourcing will set up ABC Medical as a client under one of the following categories depending on the level of activities required.

  • Virtual Incubator
    Client has their own office space somewhere else and will only use the general cubicles and conference rooms as needed.
  • Physical Incubator
    Client plans to have a physical presence at the LSO facility and needs an office to lease.

In both cases, Life Science Outsourcing will transfer, organize, and maintain all existing documentation and will provide a gap analysis with the client. A Life Science Outsourcing project leader will then be assigned to the company. Life Science Outsourcing will commit the full breath of its internal resources, along with outside approved suppliers to create prototypes or clinical samples for first in man testing. In addition, the client registration with FDA / ISO organizations will be facilitated using Life Science Outsourcing’s address and developing quality system procedures, allowing the client to interact with our support services.

Based on the established timelines and depending on the plans, eventually the client will have one or all of the following:

  • FDA registration as the Manufacture of the record (OEM)
  • ISO 13485 certification with a notified body
  • 510K submission and approval for their device
  • CE Marking for their product

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