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Packages
Clinical investigation
This package provides expert support for the planning, management, and oversight of clinical investigations for medical devices. It includes guidance on study design, regulatory and ethical compliance, clinical documentation, risk management, and coordination throughout the investigation process to help demonstrate the safety and performance of your medical device while meeting applicable regulatory requirements.
Technical file review
This package provides a comprehensive review of your medical device technical documentation to assess compliance with applicable regulatory requirements, including the Medical Device Regulation (MDR). Services include evaluation of technical documentation, identification of compliance gaps, review of supporting evidence and essential documentation, and recommendations to strengthen your technical file in preparation for regulatory submissions, audits, or conformity assessments.
Regulatory strategy
This package provides strategic regulatory guidance to support the successful development and market approval of medical devices. Services include regulatory pathway planning, classification and market access strategy, submission planning, gap analysis, and tailored compliance advice to help meet applicable regulatory requirements efficiently and throughout the product lifecycle.
MDR
This package provides expert guidance to help manufacturers achieve and maintain compliance with the Medical Device Regulation (MDR). Services include support with regulatory strategy, technical documentation, clinical evaluation, risk management, post-market surveillance, and overall compliance with applicable MDR requirements to facilitate successful regulatory submissions and market access.
FDA
This package provides expert guidance to support compliance with U.S. Food and Drug Administration (FDA) requirements for medical devices. Services include regulatory strategy, device classification, premarket submission support, quality system compliance, technical documentation review, and regulatory guidance to help prepare for successful market entry and ongoing compliance in the United States.
13485
This package provides expert support to help organisations achieve and maintain compliance with ISO 13485, the international standard for medical device quality management systems. Services include quality management system development and review, gap analysis, documentation support, internal audit preparation, process improvement, and guidance to help ensure ongoing compliance and certification readiness.