Clinical evaluation
We develop clinical strategies and prepare clinical evaluation documents. Get a clear assessment of your evidence and a plan for addressing the gaps.
- Clinical strategy
- Clinical evaluation plans
- Clinical evaluation reports
Evidence
that stands up
to scrutiny
Clinical, biocompatibility and post-market evidence for your medical device or IVD.Use our platform. Or ask our experts.
Trusted by
Your evidence. Our platform.
From thousands of records to a traceable report. In minutes.
Search, screen, appraise, extract and synthesise in one place. AI assistants propose. Your team reviews and decides.
Explore the platformYour notified body’s next question.Already addressed.
Get recommendations on sources, objectives and criteria, grounded in regulatory guidance. Turn them into your review plan in one click.
Explore the platformSources suggested for your device
Literature
PubMed
Europe PMC
PMC
Cochrane
Google Scholar
Wiley
IEEE Xplore
OpenAlex
medRxiv
bioRxiv
MAG OnlineRegisters
ICTRP
PROSPEROHealth technology assessment
INAHTA NICE HAS IQWiG G-BA KCE ZIN Agenas AQuAS HIQA SBU AIHTA NIHR CDA-AMC AHRQClinical guidelines
ESC EAES EAN AWMF DKG SIGN Current Care AAOS ACP ASCO IDSA CTFPHC JBI
Standards and guidance
ISO
IEC
CENELEC
MDCG
DIN
BSI
ETSI
NISTDevice registers
EUDAMED GUDID AusUDID
Incidents
openFDA DAEN MDIDSafety notices
FDA WHO MHRA BfArM Ministero della Salute ANSM SARA BASG Swissmedic ΙΥ&ΥΔΥ Health Canada ANVISA Infarmed Läkemedelsverket SÚKL IGJ DKMA AEMPS HPRA HSA PMDA FAMHP Medsafe
Objectives suggested for your device
- Is the device safe in its intended use?
- Does it perform as the manufacturer claims?
- What is the current standard of care for the condition?
- How does it compare with the alternatives?
- Which adverse events are reported in the field?
- Which residual risks need to be addressed?
- Do the benefits outweigh the risks?
- Which patient groups does the evidence cover?
- Which outcome measures do the studies use?
- What do the clinical guidelines recommend?
- Are there recalls or safety notices for similar devices?
- Which gaps need post-market clinical follow-up?
- What evidence is available on longer-term outcomes?
- Are the clinical data sufficient for every indication?
- Are there trends in complaints or incidents?
- Which studies are ongoing or registered?
Ready to submit
Literature search protocol
P
I
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Inclusion
Exclusion
Your device. Our expertise.
Biocompatibility
We assess biological safety and prepare biocompatibility documentation. Identify evidence gaps and testing needs based on your device’s materials, use and risk profile.
- Biological evaluation plans
- Evidence gaps and testing strategy
- Biological evaluation reports
Post-market surveillance
We plan and run post-market surveillance, from data collection to PSURs and PMCF integration. Turn findings into clear reports and actions for your device.
- Post-market surveillance plans
- Periodic safety update reports
- PMCF planning and reporting
State-of-the-art analyses
We analyse current clinical practice, treatment alternatives and relevant benchmarks. Give your clinical evaluation a clear basis for assessing safety and performance.
Real-world evidence
We design and run PMCF studies, registries and observational studies. Generate clinical data that answers the questions that matter for your device.
Usability engineering
We plan and run usability engineering to IEC 62366-1 and IEC 60601-1-6, from use specification to summative evaluation. Show that users can operate your device safely.
Risk management
We connect risk management with clinical evaluation, biocompatibility and post-market surveillance.
Technical documentation
We compile technical documentation to MDR and IVDR Annexes II and III, and submission files for the FDA, TGA and SFDA.
Quality management
We set up and maintain quality management systems to ISO 13485.
Your trust. Our track record.
“Meticulous attention to detail and dedication to producing high-quality work are evident in every project we've worked on together.”
Kolja B.
Senior Medical Affairs & Clinical Executive
“They bring tremendous Clinical Med Device knowledge and experience to the table and helped us through multiple EU MDR Initiatives.”
Michael S.
Director, RAQA PMO
“They consistently delivered high-quality, MDR-compliant clinical evaluation writing services with professionalism and precision.”
Durga P.
Senior Manager Clinical Evaluation
“Contributions to CERs, CEPs, and SSCP documents have been invaluable, demonstrating a profound understanding of both the medical and regulatory aspects of the field.”
Lizz B.
Director, Evidence Evaluation
“Im Rahmen des MDR-Transfers unseres Produktportfolios konnten wir gemeinsam pragmatische und dennoch sehr detaillierte klinische Bewertungskonzepte entwickeln und umsetzen, die der überaus kritischen Bewertung unserer Benannten Stelle standhielten.”
Jan S.
Chief Technology Officer & Head of RA & QM
“Ihre professionelle Expertisen für eine beschleunigte Time-to-Market, Präzision und zuverlässige Partnerschaft machen sie zu einem ausgezeichneten Unternehmen.”
Martin E.
Founder & CEO
“Insights, dedication, and attention to detail greatly contributed to the success of our initiatives.”
Fabian S.
Managing Partner
“They demonstrated their ability to guide a product idea through to market approval and beyond.”
Jonathan V.
Senior Regulatory Affairs Manager
“Für die erfolgreiche Zulassung einer der ersten SaMD Klasse IIa nach MDR war seine Expertise und der sehr gute und hilfreiche Austausch maßgeblich mit verantwortlich.”
Eva H.
Regulatory Affairs Manager
“Valuable guidance to establish the Clinical Evaluation process for the QMS, emphasising the distinctions between MDD and MDR and how to gather evidences for a specific SaMD product.”
Tania S.
QA Officer / PRRC (SaMD)
“Really an expert on Clinical Evaluation for MDR and IVDR.”
Monir E.
Founder & CEO
“He helps with the definition of medical claims, risk management, links everything with post-market surveillance, and only then covers it with clinical evaluation.”
Vaclav V.
Quality Management Representative
“Instrumental in helping us setting up our QMS system, giving clear advices and helpful indications to create our documentation, especially related to the Clinical Evaluation process for Medical Device Software.”
Fabio B.
Medical Writer / Project Manager
“We brought him in after our first clinical round and were able to pass in two rounds.”
Linda H.
Regulatory Affairs Director
“The result is a scientifically strong clinical evaluation that we and the regulators can trust.”
Julia L.
Sr Director of Regulatory Affairs and Clinical
“Deep understanding of the clinical evaluation process and the evolving European regulatory requirements brought clarity at a time when even Notified Bodies were still navigating the changes.”
Mara C.
Chief Transformation Officer
“It is hard not to appreciate his brilliant and creative mind, his solid knowledge and the quality of his working method.”
Marta M.
Clinical Science Manager
“Delivered with precision, on time, and with a deep understanding of our needs.”
Anna W.
Senior Global Scientific Marketing Manager
“Using the platform, I completed a full CER within three weeks.”
Vijaya Bhaskar T.
EU MDR Regulatory Affairs, Clinical Evaluation
“His regulatory knowledge and experience are exceptional, and he played a key role in helping us prepare for and successfully defend our technical documentation during NB review.”
Devendra D.
Regulatory Affairs Program Manager
Let’s talk.
“They consistently delivered high-quality, MDR-compliant clinical evaluation writing services with professionalism and precision.”
Durga Prasad Gaddam
Senior Manager Clinical Evaluation, LivaNova
“Using the platform, I completed a full CER within three weeks. […] The CER passed a Notified Body audit with zero findings.”
Dr. Thanga Bhuvanesh Vijaya Bhaskar
EU MDR Regulatory Affairs, Clinical Evaluation