Managing the risk throughout the development and project life-cycle is key to the successful commercialization. Leverage our experience to ensure your organization processes are driven to manage the risk and compliance as per applicable standards.

Based on the intended use, type and classification of your product, we will help you design and optimize your internal procedures to manage the product and process risks, hazards and achieve compliance as per applicable standards MDD 93/42/EEC, FDA 21 CFR 820, ISO 13485, IEC 60601, ISO 14971, IEC 62304, HE 75, DICOM, PACS, HIPAA and HL7.

Contact us for new product development initiatives. We can help you capture and embed the regulatory compliance requirements in your solution architecture and plan an approval roadmap. For your legacy solutions, contact us for your remediation projects and we will help you close the non-conformances and CAPAs.