IoC®[Internet of Care]

From your initial requirements to commercial roll-out, IoC®[Internet of Care] gives you access to a range of resources and know-how ensuring the success of your smart device.

A One-stop shop for designing and manufacturing your smart electro-medical device

In view of the current trend for digital transformation, health professionals and patients are changing their practices and new features are being added to medical devices. These are useful for monitoring medical data, enabling patients to stay at home, and ensuring that treatments are taken more safely. A number of challenges are faced and form the basis of fundamental goals in terms of: optimising monitoring of constants, enabling health professionals to manage situations, simplifying care pathways, and improving patient comfort.

Stiplastics Healthcaring has been ISO 13485-certified for over 15 years and has recently extended the scope of its certification to include the manufacture, incorporation and packaging of electro-medical devices. From design to delivery, each product meets the requirements of the pharmaceutical quality system since we train all our staff in Good Manufacturing Practices. We have joined forces with some first-class partners to create the IoC®[Internet of Care] platform enabling us to develop smart electro-medical devices.

We harness all our expertise in terms of design, manufacture, CE marking, and global supply to meet your requirements.

IoC

Services & know-how

From your initial requirements to commercial roll-out, IoC®[Internet of Care] gives you access to a range of resources and know-how ensuring the success of your smart device.

Regulatory compliance

Our job is to guide you smoothly and agilely through a complex and ever-changing regulatory environment.

Our MDs are produced in accordance with regulations and standards, among others:

  • NF EN 60601: safety and essential performances of medical electrical equipment
  • NF EN 62304: development and maintenance of MD software
  • ISO 14971: application of risk management to MDs
  • NF EN 62366-1: application of usability engineering to MDs

IoC

The MDs we design can be developed both American or European regulation, depending on your marketing requirements.

Design & intellectual property

From your initial requirements to the production phase, our designers, engineers and regulatory specialists are tasked with:

  • Drawing up functional speci_cations (usability, risk analysis, specification)
  • Generating concepts, prototypes or realistic rendering
  • Mechanical, electronic and software development
  • Pilot series
  • Providing guidance on clinical evaluation

We manage procedures concerning the protection of industrial property (assistance with analysing and filing patents)and CE marking (preparing the technical file, interface with notified bodies and certification laboratories). We also help you manage data (hosting, processing and analysis).

IoC

Manufacturing & assembly

With our state-of-the-art industrial facility,we ensure the following:

  • Managing manufacturing tools
  • Plastic injection
  • Incorporation of electronic components into plastic solutions
  • Assembly using robot gluing, electronic screwing, welding
  • Visual inspections and development of serialization software
  • Functional tests at each stage of integration
  • Monitoring of mechanical, electronic and software manufacture using a MES (Manufacturing Execution System), managing batch records
  • Full traceability of all components
  • Tailor-made packaging (cardboard, plastic, fabric)
  • Worldwide deliveries

From plastic to plastronics, we inject intelligence into your devices

Stiplastics Healthcaring

SGH Healthcaring Group

62, chemin des plantées
38160 Saint-Marcellin - France

Contact@stiplastics.com
Tél. : +33 (0)4 76 38 08 44
Fax. : +33 (0)4 76 38 54 39