Planning and reporting according to IVDR 2017/746 from Class A to Class D.
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Efficient continuous process of post-market surveillance for IVDs and medical devices.
Discuss your regulatory (MDD / MDR), developmental or strategic questions with our experts.
Do we really need a study? If so, how should our study look like, what are the best endpoints and where should we conduct it?
Professional literature searches by expert medical writers on new technologies, indications, targets, and more.
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Permissible daily exposure
Establishing limits on daily intake of a substance to ensure safety & prevent adverse effects.
Occupational exposure limit
Comprehensive assessment of OEL to safeguard workers from hazardous substance exposures.
Health-based exposure limit
Detailed assessment of maximum substance exposure without adverse health effects to ensure individual safety and wellbeing.
Environmental risk assessment
Systematic evaluation of environmental hazards & impacts in an ERA process and report.
Acceptable & Tolerable daily intake
Assessment of safe ingestion levels of substances in ADI & TDI values for daily human consumption.
Toxicological assessment
Detailed evaluation of substance hazards & potential health impacts in a toxicological review and report.
We will be happy to answer any questions you might have via e-mail or in a free online kick-off meeting.
