ISO 13485 - Consulting
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We work with medical device manufacturers to implement effective quality management systems. See how we can help you to achieve ISO 13485 certification.
ISO 14971 - Consulting
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We work with medical device manufacturers to implement effective quality management systems. See how we can help you to achieve ISO 14971 certification.
Experienced Consulting
Trusted Partner
Foton Consulting consults large Fortune 100 medical device organizations and small to mid-size companies. We focus on quality management system (QMS) implementation and maintenance.
With over 20 years of experience in international management system standards. We are a trusted partner and deliver exceptional results in a cost-effective manner and guarantee customer satisfaction.
Consultation Services
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ISO 13485
Compliance with ISO 13485 is often viewed as the initial step in ensuring adherence to European regulatory requirements. This is particularly significant when it comes to assessing the conformity of Medical Devices and In-vitro Diagnostic Medical Devices in accordance with European Union Directives 93/42/EEC, 90/385/EEC, and 98/79/EEC before allowing their sale.
EUMDR Consulting
Compared to the MDD, the scope of the MDR has been expanded to cover not only the active implantable medical devices previously covered by the Active Implantable Medical Device Directive 90/385/EWG (AIMDD) but also a range of products without an intended medical purpose.
IEC 62304
The IEC 62304 standard calls out certain cautions on using software, particularly SOUP (software of unknown pedigree or provenance). The standard spells out a risk-based decision model on when the use of SOUP is acceptable, and defines testing requirements for SOUP to support a rationale on why such software should be used.
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Foton Consulting
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Dover, DE 03820