Electromedical products

Electrical medical devices are regulated by the IEC 60601-1 standards, containing safety requirements for all electrical medical devices. IEC 60601-1 consists of:

The General safety standard: IEC 60601-1, applicable for all products.
A number of Collateral standards: IEC 60601-1-XX. These are part of the general standard, but deals with issues too complex to be brought up in the general standard. Examples of collateral standards are: EMC (IEC 60601-1-2), Alarm systems (IEC 60601-1-8) etc.
A number of Particular standards, for specific devices. These standards are also known as product standards and are used together with the general and the collateral standards. The demands in the particular standards are more detailed than in the general standard. Examples of particular standards: Hospital beds (IEC 60601-2-38), Laser equipment (IEC 60601-2-22), Endoscopy equipment (IEC 60601-2-18).

Services for product development

A review of the requirements according to IEC 60601
Which requirements will be applicable? We will map the requirements applicable for your product, preparing and streamlining your product development
Risk analysis and verification. We will perform an objective verification of your products.
Manuals. Generation of user manuals and service manuals containing all the information specified by the standard (the IEC 60601 family). We do everything; from content, pictures, graphics, layout and different language versions.

Services for manufacturing

Production start-up

A common problem in many industries is tech transfer – the step in which the handover from R&D to production takes place. Often, the supporting documentation is not applicable for the production, but characterized by the R&D department’s desire for flexibility. Problems may particularly occur if a contract manufacturer is involved, where the corporate culture is different and a lack of understanding between the two entities can create unnecessary friction and delay.

Help with preparing the supporting documentation. We have extensive experience in producing relevant documents, records and drawings and can support you in the production of the entire package or be of assistance in making sure that you have included all that is necessary.
Contract manufacturing. Are you planning on using a contract manufacturer for your product? We can help you with the assessment of different suppliers in order to help you find the ideal contract manufacturer to best suit your needs.
Production start-up. Do you have a finished product or prototype, but unsure of how to launch the production in an efficient manner? We will support you in finding a supplier; including qualifying them and organizing the tech-transfer!

Running production

When a production is up and running, it is not uncommon for the supporting documentation to change slightly over time, often without any records of these changes. Is your supporting documentation accurate? We will check all the supporting documentation against the product manufactured and make sure that you will pass inspections and have the tools for handling your own monitoring for future development.

Testing