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

Following is a typical set up with hypothetical client: ABC Medical

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 do everything under 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, QIS will set up ABC medical as a client under one of the following categories depending on the level of activities required. Status can be changed as objectives are achieved. For clients not in close vicinity to LSO, Virtual Incubator is usually preferred. In either case the range of services provided by QIS are exactly identical.

  • 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; QIS will transfer, organize and maintain all existing documentation and will provide a gap analysis with the client. An QIS project leader will then be assigned to the company. QIS 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 LSO’s address and developing quality system procedures, allowing the client to interact with LSO’s 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

QIS in conjunction with other LSO divisions can provide the following major categories of services:

  • Device Master Records
  • Quality Systems Documentation
  • 510K / CE Mark submission
  • Manufacturing Procedures
  • Sterilization Validations and routine sterilizations (Gamma, Steam, EO)
  • Packaging Design & Validation
  • Device History Records
  • Supply Chain Management
  • Order Fulfillment & Distribution
  • Complaint handling and CAPA
  • RGA and failure analysis
  • FDA / ISO audit support