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Our
Services

General Advisory & Strategy

  • Regulatory Strategy Development

  • Medical Device Classification

  • MDR/IVDR Transition Planning

  • Gap Analysis ​

  • Regulatory Intelligence​​​​

  • EU MDR 2017/745

  • EU IVDR 2017/746 / IVDD 

  • UK MDR 2002 (MDD 93/42/EEC)

  • US FDA 510k, De Novo, PMA, 513g

  • EU Battery Regulation

  • EU AI Act ​​​

Quality Management System

  • ISO 13485 Planning

  • Gap Analysis 

  • Development of Procedures

  • Implementation 

  • Audit Readiness

  • Mock Audit​​

Audit & Regulator Support 

  • QMS Audit Readiness

  • Technical File Audit Readiness

  • Mock Audits

  • Internal Audits

  • Declaration of Conformity

  • Registration Support

  • Notified Body Selection

  • Liaising with Notified Bodies

  • Communication with Competent Authority

Regulatory Documentation

  • Technical files (MDD, IVDD, MDR, IVDR)

  • Design Dossiers Preparation 510k, Special 510k, DeNovo, PMA)

  • Human Factors/ Usability 

  • Biological Evaluation

  • Risk Management Support

  • Clinical Investigation & Evaluation

  • Labelling & UDI

  • Economic Operator Process

  • Post-Market Clinical Follow-up

  • Post-Market Surveillance & Vigilance

Clinical Evaluation

  • Gap Assessment MDR 

  • Clinical Evaluation Plan 

  • Clinical Development Plan

  • Literature Review & Search Strategy 

  • Clinical Evaluation Report 

  • Assessment of Clinical Evidence

Training

  • EU Medical Device Regulations 2017/745

  • ISO 13485: 2016 Quality Management Systems

  • Design Controls

  • Risk Management (ISO 14971:2019)

  • Human Factors/ Usability 

  • Clinical Evaluation

  • Biocompatibility (Biological Evaluation)

  • Post-Market Clinical Follow-Up & Surveillance

  • EU Battery Regulations 2023/1542

  • EU AI Act 2024/1689 

MedTech
Partner Network

Partner Network

Cqura is proud to be part of an independent network of expert consultancies serving the medical device industry.

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We work closely with our partners to develop and implement tailored solutions that fit your specific needs — practical, efficient, and goal-oriented.

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Benefits at a Glance

  • Access multiple independent consultants through a single contractual relationship.

  • Benefit from a coordinated, multidisciplinary team without the hassle of managing multiple contracts.

  • Cqura handles all integration and coordination, ensuring a seamless experience.

  • You remain free to focus on progressing your project while we provide tailored, expert support.​

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