CLINICAL DEVELOPMENT - CRO
We support every stage of your clinical and regulatory process
We are the Clinical Development business area within GBA Key2Compliance – a full-service MedTech CRO supporting medical device and IVD companies through every stage of clinical and regulatory evidence generation.
Our consultants combine operational expertise with deep regulatory insight – helping you plan, execute, and document clinical activities in compliance with MDR, IVDR, ISO 14155, and ISO 20916.
100%
MedTech CRO
100%
NB record
20+
Clinical Experts
MDR/IVDR
Specialists
FULL
European coverage
Quality is Built In – Not Added On
As a MedTech CRO, we don’t just follow procedures – we build our services around them.
Our clinical operations are guided by well-established, process-driven frameworks. Every project is delivered with clear responsibilities, documented workflows, and risk-based oversight – from planning to final reporting.
We maintain a strong quality system with a dedicated Clinical Quality Assurance function, supporting both internal and external audits as well as regulatory inspections. Our team is regularly trained in GCP and internal procedures.
Who we are
We focus exclusively on clinical development for medical devices and IVDs – combining strategy, study execution, and regulatory alignment into one integrated service offering.
Why work with us
- MDR/IVDR specialists – not generalists
- Notified body-facing consultants
- Team of 20 clinical experts
- Scalable, flexible model (from ad-hoc to full-study ownership)
- High-touch collaboration with client teams
Who we support
Startups → Scale-ups → SME → Large enterprises → Academic innovators
We work with early-stage innovators as well as established market players navigating complex portfolios or MDR/IVDR transitions.
Capacity & Geographic Coverage
With a team of 20 consultants – primarily senior professionals – we offer flexible resourcing across clinical functions.
Based in Sweden and Denmark, we support clinical studies throughout Europe.
For region-specific execution such as site monitoring, we work with established partners to ensure full geographic coverage.
GCP Training
Looking for Good Clinical Practice training for medical devices or IVD?
We offer tailored courses as well as open trainings on ISO 14155 and ISO 20916.
Visit our training page to see upcoming sessions or get in touch for a custom solution.
It Is the team that makes the difference
“Our work is rooted in medical science, with a commitment to truly add genuine value. Meaning that we bring a sense of responsibility and ownership to every clinical project, always striving to be the seamless extension of the customer’s team.
Our aim is to work alongside you, using our expertise to bring medical technology from development to market with precision and care.”
Jeanette Demorney, Senior Advisor
Insights from our Clinical experts
Ida Björklund
Safety Manager
“Safety is an absolute, non-negotiable commitment. A commitment to your patients, to the quality and efficacy of your products, and ultimately, the reputation of your company.”
Åsa Testad,
Senior Clinical Data Manager
“Effective data management isn’t about collecting everything – it’s about planning what truly matters and ensuring it’s collected in a way that supports compliance and analysis.”
Emily Malmberg, Senior Consultant
“Early engagement with IVDR compliance not only ensures timely market access but also positions companies as leaders in quality and reliability.”
Anna Östblom, Clinical Project Manager
“The most rewarding moments are when we hit a tight deadline and stay on budget. But that’s also the biggest challenge.“
Your MedTech CRO – We navigate you right and fix what others can’t!
Choosing the wrong CRO for your clinical investigation (Medical Devices) or clinical performance
study (IVD) can lead to delays, compliance risks, and costly setbacks. Many companies mistakenly
turn to CROs that specialize in pharma – but MedTech is different.
- Missed deadlines? We accelerate and optimize.
- Regulatory roadblocks? We navigate them with MedTech expertise.
- Wrong CRO partner? We take over – and do it right.
MedTech and IVD studies require a different approach – and that’s our expertise.
Let our team of industry experts step in, assess the situation, and guide your study to success.
Navigating IVDR-Compliant Clinical Development
Our consulting team provides expert guidance in Clinical Development that is compliant with the In Vitro Diagnostic Regulation (IVDR). We design and conduct studies tailored to verify your product’s safety, performance, and effectiveness. Our expertise enables you to meet the stringent requirements of IVDR, ensuring product excellence and compliance.
Guide to Clinical Investigation Plans & Reports for Medical Devices
Regulatory demands for medical devices are stricter than ever. This guide helps you develop Clinical Investigation Plans (CIPs) and Reports (CIRs) that meet MDR, ISO 14155, and global regulatory standards.
What’s Inside?
- Step-by-step guidance on developing CIPs & CIRs – Learn how to structure your plans and reports for clarity and compliance.
- Key regulatory requirements & best practices – Understand MDR, ISO 14155, and what authorities expect from your documentation.
- Practical tips for study design & compliance – Get insights on risk analysis, study objectives, and essential data collection.
Download now and simplify your clinical investigation process!
Book a Free 1-Hour Consultation
with a Clinical MedTech Expert
Struggling with your clinical strategy? Let us help you get back on track.
Whether you’re dealing with delays, regulatory confusion, or uncertain study outcomes
– we’re here to help. As a dedicated MedTech CRO, we understand the specific
requirements under both MDR and IVDR.
Choose your free consultation focus:
• Clinical Evaluation – Medical Devices (MDR)
• Clinical Investigation – Medical Devices (MDR)
• Performance Evaluation – IVD (IVDR)
• Clinical Performance Study – IVD (IVDR)
• General Clinical Strategy Advice
Book a 1-on-1 session with one of our senior consultants. No cost. No pressure.
Just actionable advice based on deep regulatory and clinical expertise.
expand their reach to over 60 countries.
Related material
A guide to regulatory compliance
Free on-demand tutorials for start-up Medical Device companies
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Get In Touch With Our Experts
We have dedicated experts of every service of our business. Feel free to leave your contact details and we will find the right solution just for you.