Medical Care and Product Development
MEC-ABC GmbH is a leading provider of clinical evaluation, regulatory compliance, and post-market surveillance services for medical devices. They support clients in MDR conformity, clinical data management, certification processes, and market access. Their expertise includes clinical evaluation reports, technical documentation, clinical studies, post-market surveillance, and training in clinical affairs, with a focus on MDR requirements and market entry. As a trusted 'Lotse' in the industry, MEC-ABC guides companies through the complex regulatory landscape, ensuring safety, performance, and compliance of medical devices throughout their lifecycle.
Industries
Nr. of Employees
small (1-50)
Medical Care and Product Development
Products
Deficiency List 2025 (download)
Compiled list of common deficiencies in clinical evaluation assessment reports, sorted by guidance, intended as a reference to identify typical clinical evaluation deficiencies prior to submission.
Template package: Clinical evaluation and MDR whitepapers
Template package and whitepapers for clinical evaluation and conformity assessment documents to accelerate preparation of MDR-aligned documentation.
Deficiency List 2025 (download)
Compiled list of common deficiencies in clinical evaluation assessment reports, sorted by guidance, intended as a reference to identify typical clinical evaluation deficiencies prior to submission.
Template package: Clinical evaluation and MDR whitepapers
Template package and whitepapers for clinical evaluation and conformity assessment documents to accelerate preparation of MDR-aligned documentation.
Services
End-to-end preparation and review of clinical evaluation plans and reports to support MDR conformity, including state-of-the-art assessment and quantitative evidence mapping.
Identification, aggregation and evaluation of existing clinical data and literature to derive clinical endpoints, benchmarks and an evidence strategy tailored to regulatory requirements.
Development of PMS and PMCF strategies and documents, design of vigilance processes and support for PMCF activities and reporting to meet MDR obligations.
Design and operational support for PMCF studies and real-world evidence collection using vigilance data, registries, surveys and other post-market sources to address evidence gaps.
Protocol development, monitoring planning, sponsor support, regulatory and ethics submission assistance, and clinical investigation reporting per ISO 14155 and MDR.
Preparation and review of technical documentation and regulatory submissions, integrating clinical evidence, risk management and PMS outputs into the technical file.
End-to-end preparation and review of clinical evaluation plans and reports to support MDR conformity, including state-of-the-art assessment and quantitative evidence mapping.
Identification, aggregation and evaluation of existing clinical data and literature to derive clinical endpoints, benchmarks and an evidence strategy tailored to regulatory requirements.
Development of PMS and PMCF strategies and documents, design of vigilance processes and support for PMCF activities and reporting to meet MDR obligations.
Design and operational support for PMCF studies and real-world evidence collection using vigilance data, registries, surveys and other post-market sources to address evidence gaps.
Protocol development, monitoring planning, sponsor support, regulatory and ethics submission assistance, and clinical investigation reporting per ISO 14155 and MDR.
Preparation and review of technical documentation and regulatory submissions, integrating clinical evidence, risk management and PMS outputs into the technical file.
Expertise Areas
- Clinical evaluation and clinical evidence strategy
- Post-market surveillance and PMCF study design
- Clinical investigation and ISO 14155-compliant trials
- Regulatory strategy for MDR conformity and notified body interaction
Key Technologies
- Systematic literature review and PICO methodology
- PMCF study methodologies and real-world evidence (RWE) collection
- PMS data workflows and safety database interrogation
- Vigilance reporting workflows and incident management
News & Updates
BMBF promotes projects in the field of medical technology to combat epidemics, including services offered by industry-clinics.
Participation in the MEDICA 2019 trade fair was successful, with discussions and future projects.
Participation in the Digital Hub Aachen to develop digital solutions for clients.
Guidance on how to formulate safety and performance claims for medical devices.
Importance of benchmarking for clinical evaluation to demonstrate safety and efficacy.
The role of indications and target groups in defining clinical data requirements.
BMBF promotes projects in the field of medical technology to combat epidemics, including services offered by industry-clinics.
Participation in the MEDICA 2019 trade fair was successful, with discussions and future projects.
Participation in the Digital Hub Aachen to develop digital solutions for clients.
Guidance on how to formulate safety and performance claims for medical devices.
Importance of benchmarking for clinical evaluation to demonstrate safety and efficacy.
The role of indications and target groups in defining clinical data requirements.