# Qmed Consulting

> Qmed Consulting is an independent, boutique Clinical Research Organisation (CRO) and MedTech consultancy headquartered in Copenhagen, Denmark, founded in 2006. Qmed helps MedTech startups and manufacturers navigate clinical, regulatory, and quality management challenges across the EU (with support into US and Asia-Pacific through trusted partners), guiding devices from early strategy through CE marking / FDA pathways to post-market surveillance. Qmed is ISO 9001:2015 and ISO 14155:2020 certified, with 900+ completed projects, 400+ Class III devices supported, 53,000+ patients across clinical studies, and 100+ specialists across Europe.

Qmed positions itself as "not just a CRO — a partner," working under a three-part method: Listen, Lead, Deliver. Services are organised around four lifecycle stages — Plan, Execute, Market Access, and Post-Market — and two core practice areas: Clinical Affairs and Regulatory Affairs. Qmed serves both funded early-stage startups preparing first submissions and established manufacturers scaling into new markets or transitioning to MDR/IVDR. Qmed's stated strength is Europe/CE marking; for US FDA pathways it works through trusted external partners.

## Company

- [Home](https://qmed-consulting.com/): Overview of Qmed as a European full-service CRO and MedTech partner; company stats, service pillars (Plan/Execute/Market Access/Post-Market), client testimonial, and contact form.
- [About](https://qmed-consulting.com/about/): Company history (founded 2006), mission ("turning complexity into clarity"), the Qmed Way (Listen, Lead, Deliver), and management team profiles.
- [Services](https://qmed-consulting.com/services/): Full description of Qmed's service model across Plan, Execute, Market Access, and Post-Market stages, spanning Clinical Affairs and Regulatory Affairs.
- [Contact](https://qmed-consulting.com/contact/): Contact form and direct contact details for project inquiries.
- [Resources](https://qmed-consulting.com/resources/): Articles, podcast episodes (The Qmed Podcast), and webinars on MedTech regulatory and clinical topics.
- [General Terms and Conditions](https://qmed-consulting.com/general-terms-and-conditions/): Legal terms governing engagements with Qmed Consulting.

## Clinical Affairs

- [Clinical Affairs](https://qmed-consulting.com/services/clinical-affairs/): Hub page for Qmed's clinical operations services covering trial design through data management and post-market studies.
- [Clinical Research Organisation (CRO)](https://qmed-consulting.com/services/clinical-affairs/clinical-research-organisation-cro/): Full-service and fractional CRO support for MedTech clinical studies.
- [Clinical Investigation for Medical Devices](https://qmed-consulting.com/services/clinical-affairs/clinical-investigation-for-medical-devices/): Design and execution of clinical investigations under MDR/ISO 14155.
- [Clinical Trial Management](https://qmed-consulting.com/services/clinical-affairs/clinical-trial-management/): End-to-end or modular management of MedTech clinical trials.
- [Clinical Trial Services](https://qmed-consulting.com/services/clinical-affairs/clinical-trial-services/): Targeted, á la carte clinical trial support services.
- [Clinical Trial Management Systems (CTMS)](https://qmed-consulting.com/services/clinical-affairs/clinical-trial-management-systems-ctms/): Systems and tools supporting clinical trial oversight and coordination.
- [Clinical Data & Analytics](https://qmed-consulting.com/services/clinical-affairs/clinical-data-analytics/): Clinical data handling and analysis to support evidence generation.
- [Data Management](https://qmed-consulting.com/services/clinical-affairs/data-management/): Structured data management processes for clinical studies.
- [Clinical Evaluation Report (CER)](https://qmed-consulting.com/services/clinical-affairs/clinical-evaluation-report-cer/): Preparation of Clinical Evaluation Reports under EU MDR.
- [PMCF Studies](https://qmed-consulting.com/services/clinical-affairs/pmcf-studies/): Post-Market Clinical Follow-up study strategy, design, and execution.
- [Post-Market Studies](https://qmed-consulting.com/services/clinical-affairs/post-market-studies/): Broader post-market clinical study support beyond PMCF.

## Regulatory Affairs

- [Regulatory Affairs](https://qmed-consulting.com/services/regulatory-affairs/): Hub page for Qmed's regulatory strategy, submission, quality, and post-market compliance services.
- [Medical Device Regulatory Strategy](https://qmed-consulting.com/services/regulatory-affairs/medical-device-regulatory-strategy/): Early-stage regulatory pathway definition and strategic planning.
- [Medical Device Classification (MDR)](https://qmed-consulting.com/services/regulatory-affairs/medical-device-classification-mdr/): Device classification support under EU MDR.
- [EU MDR Consulting](https://qmed-consulting.com/services/regulatory-affairs/eu-mdr-consulting/): Consulting on compliance with EU Medical Device Regulation (2017/745).
- [IVDR Consulting](https://qmed-consulting.com/services/regulatory-affairs/ivdr-consulting/): Consulting on compliance with the EU In Vitro Diagnostic Regulation (2017/746).
- [Clinical Evidence Strategy](https://qmed-consulting.com/services/regulatory-affairs/clinical-evidence-strategy/): Aligning clinical evidence generation with regulatory and market objectives.
- [Clinical Development](https://qmed-consulting.com/services/regulatory-affairs/clinical-development/): Overall clinical development planning aligned with regulatory strategy.
- [Clinical Study Design](https://qmed-consulting.com/services/regulatory-affairs/clinical-study-design/): Designing compliant, fit-for-purpose clinical studies.
- [Clinical Trial Regulatory Requirements](https://qmed-consulting.com/services/regulatory-affairs/clinical-trial-regulatory-requirements/): Guidance on regulatory requirements applicable to clinical trials.
- [ISO Standards for Clinical Research](https://qmed-consulting.com/services/regulatory-affairs/iso-standards-for-clinical-research/): Guidance on applicable ISO standards (e.g., ISO 14155) for clinical research.
- [ISO 13485 Consulting](https://qmed-consulting.com/services/regulatory-affairs/iso-13485-consulting/): Quality management system consulting under ISO 13485.
- [Quality Management](https://qmed-consulting.com/services/regulatory-affairs/quality-management/): Broader quality management system support for MedTech manufacturers.
- [Risk Management](https://qmed-consulting.com/services/regulatory-affairs/risk-management/): Medical device risk management support (e.g., ISO 14971 alignment).
- [Technical Documentation](https://qmed-consulting.com/services/regulatory-affairs/technical-documentation/): Preparation of MDR/IVDR technical documentation files.
- [UDI & EUDAMED](https://qmed-consulting.com/services/regulatory-affairs/udi-eudamed/): Unique Device Identification and EUDAMED registration support.
- [Post-Market Surveillance (PMS)](https://qmed-consulting.com/services/regulatory-affairs/post-market-surveillance-pms/): Structured post-market surveillance systems and processes.
- [PSUR](https://qmed-consulting.com/services/regulatory-affairs/psur/): Periodic Safety Update Report preparation and ongoing regulatory reporting.

## Optional

- [Erasure Policy](https://qmed-consulting.com/wp-content/uploads/2026/04/Erasure-policy_Qmed.pdf): PDF document outlining Qmed's GDPR data-erasure request policy.
- [LinkedIn](http://linkedin.com/company/qmed-consulting/): Qmed Consulting's official company LinkedIn profile.
- [The Qmed Podcast](https://qmed-consulting.com/podcasts/): Series of expert-guest podcast episodes on MedTech regulatory and clinical topics.