Equipment Maintenance

Service is an important part of the business of COCIR membership, way beyond traditional service contracts and maintenance. With increasingly personalized service requirements, the roles and responsibilities between provider and customer may need to be redefined. While servicing is not necessarily subject to medical device regulation, links exist. It is now being recognized by regulators that medical devices can be safe only when properly used/serviced.

COCIR's definition of servicing includes all activities ranging from hand-over to the customer until the disposal of the product (training, remote services, maintenance, legal responsibility of customers, any modification of the product, prevention of misuse, etc.)

COCIR  created a dedicated task force on servicing  which developed an industry "Good Maintenance Practice Guide" including the definition of service and reference to international standards.

COCIR also aims to:

  • Develop a glossary of terms relative to servicing;
  • Assess regulatory gaps and propose solutions to fill these;
  • Take part in the development of new international standards related to maintenance and servicing.