Assessments by trained specialists
20 years of scientific and regulatory experience
Without data, you're just another person with an opinion.
— W. Edwards Deming
An experienced & scientific foundation
Expert statements provide high level written opinions and assessments on debated topics in law, regulatory and strategic business decisions.
Law
At IASON consulting, we offer expert statements addressing regulatory and medical affairs and patient health to support your legal proceedings with precision and credibility.
Regulatory
In complex scenarios such as drug-device categorization, regulatory authorities often seek or can be convinced by well-informed expert opinions. We specialize in providing precisely that level of expertise.
Business decisions
Adding new perspective from an expert can be just as valuable for strategic decision makers than receiving confirmation on a new business idea or acquisition project.
Impurities and contaminants
A toxicological expert statement is crucial when pharmaceutical batches contain unexpected impurities or contaminants. Delving into these impurities, our experts evaluate their potential risks to human health based on their nature and concentration. If these contaminants remain within safety limits, the batch might be approved for distribution.
Essentially, this statement ensures only safe pharmaceuticals and devices reach consumers.
Medical device classification
Determining the right risk classification for medical devices under MDR 2017/745, in light of MDCG 2021-24 and MDCG 2022-5, is challenging for manufacturers. The intricate criteria, combined with overlapping guidelines, create ambiguities, risking misclassification, regulatory delays, and increased costs.
Claim validation
Claims about a medical device or a drug must be thoroughly substantiated to ensure they accurately reflect the device's safety, efficacy, and performance. This substantiation is crucial both for regulatory compliance and to instill confidence among healthcare professionals and end-users. One common and effective method to validate these claims is through a literature search, where relevant scientific papers and studies are systematically reviewed to gather supporting evidence. This approach ensures that claims are not only credible but are also rooted in empirical data and established research.
Statements to adverse events
Statements addressing adverse events related to medical devices or drugs are of paramount importance in the healthcare sector. When such events are reported to governmental registers and databases, manufacturers have a responsibility to respond promptly and comprehensively. Having an experienced toxicologist or regulatory expert on board can be invaluable, ensuring that the response is both scientifically sound and compliant with regulatory standards. Their expertise guarantees that the manufacturer's statement is accurate, thorough, and aligned with patient safety concerns, reinforcing the credibility and trustworthiness of the company.
Individual statements
Whether you’re seeking evidence-based recommendations, the latest advancements in medical technology, or informed opinions on healthcare policy, our expert statements serve as a valuable reference. We are dedicated to serving your diverse needs and can provide expert answers to a wide range of questions in the medical field.
Frequently asked questions
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