Regulatory requirements and customer needs have driven Intersurgical to obtain certification of our Quality and Environmental Management Systems. We comply with the highest standards and regulations in order to legally design, manufacture, distribute and sell medical devices throughout the world and to give our customers confidence that our products are of the highest quality.
FDA 21 CFR 820 – Quality System Regulation (QSR), USA
Outlines Current Good Manufacturing Practice (CGMP) regulations. FDA 21 CFR Part 820 is the quality system approved by the FDA. Ensures that medical devices are both safe and effective. Medical device manufacturers undergo FDA inspections to ensure FDA 21 CFR compliance.
All Intersurgical manufacturing sites are registered with the Food and Drug Administration (FDA) and meet applicable requirements and specifications outlined by FDA 21 CFR Part 820.
ISO 13485:2016 – Medical Device Quality Management Systems
The basis of all regulatory requirements for placing medical devices worldwide markets is ISO 13485:2016. Regular audits by SGS help to monitor and improve our management systems.
Intersurgical Quality Policy
We provide high quality products, which meet or exceed the mandated requirements from the differing global Medical Device Regulations and specific Standards, whilst fulfilling our customer requirements in respect of safety, effectiveness and performance. Please view our Quality Policy.
Intersurgical Environmental Policy
We are committed to minimizing the environmental impacts of the company’s products, activities and services and to continually review and reduce our carbon emissions, with an aim to achieve Net Zero by 2045. Please see our full Environmental Policy.
Intersurgical products are designed to comply with applicable European and International product standards which ensures that performance requirements are met and that our products can be safely used with devices and equipment made by other manufacturers who work to the same standards.