MDProject
Independent quality and regulatory affairs consultancy for the medical device sector. Provides regulatory strategy, technical documentation, quality management system implementation, clinical evaluation, biocompatibility assessment, process and software validation, auditing and training to device manufacturers, software developers, suppliers, distributors and healthcare institutions.
Industries
Nr. of Employees
small (1-50)
MDProject
Alphen Aan Den Rijn, Zuid-Holland, The Netherlands, Europe
Products
Quality Management System Implementation
Implementation and integration of ISO 13485:2016 compliant quality management systems tailored to medical device regulations including EU MDR/IVDR and FDA 21 CFR Part 820.
Technical Documentation and Regulatory Support
Assistance in creating, maintaining, and reviewing technical dossiers, design history files, and regulatory submissions for medical devices.
Process and Software Validation
Validation of manufacturing processes and software development processes to ensure compliance with regulatory standards.
Clinical and Biological Evaluation
Conducting clinical evaluations and biological safety assessments to support medical device compliance.
Training and Coaching on Regulatory and Quality Requirements
Providing training sessions and on-the-job coaching on medical device regulations, quality management systems, and related standards.
Consultancy for Medical Device Software Development
Guidance on integrating regulatory and quality standards into medical device software development processes.
Quality Management System Implementation
Implementation and integration of ISO 13485:2016 compliant quality management systems tailored to medical device regulations including EU MDR/IVDR and FDA 21 CFR Part 820.
Technical Documentation and Regulatory Support
Assistance in creating, maintaining, and reviewing technical dossiers, design history files, and regulatory submissions for medical devices.
Process and Software Validation
Validation of manufacturing processes and software development processes to ensure compliance with regulatory standards.
Clinical and Biological Evaluation
Conducting clinical evaluations and biological safety assessments to support medical device compliance.
Training and Coaching on Regulatory and Quality Requirements
Providing training sessions and on-the-job coaching on medical device regulations, quality management systems, and related standards.
Consultancy for Medical Device Software Development
Guidance on integrating regulatory and quality standards into medical device software development processes.
Services
Quality and regulatory consultancy
Advisory services covering regulatory strategy, QMS implementation, technical documentation, conformity assessment support and dossier preparation.
Clinical evaluation and scientific writing
Clinical evaluation process support, PMCF planning and scientific report writing to demonstrate clinical evidence and post-market performance.
Biocompatibility evaluation
Assessment and interpretation of biological safety for device materials and products.
Process and software validation
Validation of manufacturing processes, sterilization and software used in devices or QMS processes; equipment qualification and validation planning.
Auditing and supplier audits
Internal QMS audits and supplier audits to assess compliance with ISO 13485 and other regulatory requirements.
Training (classroom, in-company, on-the-job)
Regular classroom training and tailored in-company sessions on MDR/IVDR, ISO 13485, risk management, IEC 62304, internal auditor training and other regulatory topics.
Quality and regulatory consultancy
Advisory services covering regulatory strategy, QMS implementation, technical documentation, conformity assessment support and dossier preparation.
Clinical evaluation and scientific writing
Clinical evaluation process support, PMCF planning and scientific report writing to demonstrate clinical evidence and post-market performance.
Biocompatibility evaluation
Assessment and interpretation of biological safety for device materials and products.
Process and software validation
Validation of manufacturing processes, sterilization and software used in devices or QMS processes; equipment qualification and validation planning.
Auditing and supplier audits
Internal QMS audits and supplier audits to assess compliance with ISO 13485 and other regulatory requirements.
Training (classroom, in-company, on-the-job)
Regular classroom training and tailored in-company sessions on MDR/IVDR, ISO 13485, risk management, IEC 62304, internal auditor training and other regulatory topics.
Expertise Areas
- Regulatory compliance and submissions (EU MDR/IVDR, FDA pathways)
- Quality management systems (ISO 13485 implementation and auditing)
- Clinical evaluation and PMCF
- Medical device software development and software validation
Key Technologies
- ISO 13485
- IEC 62304 (medical device software lifecycle)
- IEC 62366 (usability engineering / human factors)
- IEC 60601 series (electrical medical equipment requirements)