Regulatory compliance consultancy: Medical Devices and IVD

Service description

This service supports companies in achieving regulatory compliance for medical devices, in vitro diagnostic (IVD) products, and related technologies. It covers major international frameworks including FDA, MDR, IVDR.

The service includes:
1. Regulatory Assessment: Evaluation of product classification and applicable regulations.
2. QMS Implementation: Deployment of ISO 13485-compliant systems and support for MDSAP and GMP.
3. Inspection Readiness: Preparation for audits and inspections through mock assessments and documentation review.
4. Software Validation: Validation of medical software in accordance with IEC 62304, TIR45, TIR57, and ISO 80002.
5. Training and Education: Delivery of tailored training sessions on regulatory updates and best practices.

The service typically lasts between 4 to 8 months, depending on the product type and regulatory pathway. The service is aimed at startups, SMEs, and scale-ups in the medical technology and diagnostics sectors seeking market access or preparing for audits and inspections. The goal of the service is to ensure that products meet all applicable regulatory requirements and quality standards, enabling safe commercialisation and global distribution. The service is delivered through a combination of remote consultations and on-site support, ensuring flexibility and responsiveness to client needs.

Sector

Biotechnology

Health and medical care

Pharmaceuticals

Technology Readiness Level

TRL 1 – Basic principles observed

TRL 2 – Technology concept formulated

TRL 3 – Experimental proof of concept

TRL 4 – Technology validated in lab

TRL 5 – Technology validated in relevant environment

TRL 6 – Technology demonstrated in relevant environment

TRL 7 – System prototype demonstration in operational environment

TRL 8 – System complete and qualified

TRL 9 – Actual system proven in operational environment

Financial requirements

Start from €5000/project.

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