Service Package Deliveries
Examples of how GRAHN MedX Consulting can support your medtech company with focused, senior-led deliveries.
Project Management
Hands-on leadership for complex projects, coordinating product development, design, quality, regulatory, and clinical activities toward clear milestones and submissions.
CE-marking project support
Preparation or review of Clinical Evaluation Reports with systematic literature review, equivalence justification, and gap analysis for MDR compliance.
Interim/fractional QA/RA Manager
Senior QA/RA management one or two days per week, enable no need of full-time recruitment in early phase.
ISO 13485 QMS Setup
Design and implementation of a scalable proportionate ISO 13485 Quality Management System tailored to your organization size, risk class, development phase and product portfolio. New establishment or further development.
MDR/IVDR Gap Assessment & Remediation Plan
A structured review of your technical documentation, QMS, and clinical evidence against MDR/IVDR requirements, with a concrete remediation roadmap and priority matrix.
US Market Entry Readiness & Submission Support
Initial assessment of regulatory pathway, relevant FDA requirements and needs prior to any submission process. E.g. end-to-end support in preparing a 510(k) submission package, including predicate analysis, substantial equivalence strategy, and response to FDA questions.
Notified Body Readiness Review
A pre-audit simulation and documentation review to identify weaknesses before the notified body or FDA inspection, reducing risk of non-conformities.
Risk Management File (ISO 14971)
Development or update of risk management files, including risk analysis, evaluation, control measures, and residual risk documentation.
Independent Internal Audit
Internal audit according to ISO 13485 and/or MDR/IVDR, with practical improvement suggestions and follow-up.