Certified for development and manufacturing of medical devices


Quality and standards compliance

Integer is certified for development and manufacturing of medical devices according to ISO:13845:2016 by the Standards Institute of Israel.

All of the development and manufacturing processes are supported by the quality department – both at the documentation level and at the execution level. Beginning with the processes of documenting the development through to the manufacturing and assembly processes in the clean room.

In order to enable our customers to develop medical devices with maximum flexibility, according to specific requirements and needs, Integermaintains a delicate balance between regulation, engineering creativity, and technological innovation. The standardization processes are integrated to the appropriate extent required for each stage while assuring the dynamism of the research and development process.

The Integer quality system is constructed adaptively to suit the customer needs and the documentation and quality requirements adopted by the customer. Throughout the entire process there is close, open interface between the Integerteam and the customer’s regulatory and quality consultants.

Regulatory factors are taken into consideration by the Company’s experienced engineers, who are well-versed in the regulatory and quality requirements. This concept improves the research and development processes, shortens timetables and helps achieve the final product in compliance with the required standards.

Integer writes and adopts special quality processes according to the customer’s needs and quality requirements which are not part of the standards (SOP), and also adopts additional standards:



ISO 11607-1:2006

Packaging sterilized devices

ISO 2859-1 – 1999

General – Sampling

ISO 10993-1 – 2009

General – Biological Evaluation

ISO 14971 – 2012

General – Risk

ISO 13485 – 2016

General – QMS
Clean room & control

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