WHY NOW
Why technical requirements deserve closer attention
Three developments determine how much effort a substantiated response to a criteria catalog takes.
Criteria catalogs keep growing
Evaluation matrices with hundreds of criteria are worked through by hand, often across several procedures at once. Product attributes, reprocessing, service, and evidence sit in different documents.
Standard questions tie up specialist capacity
Recurring questions about product properties and evidence are answered from scratch again and again. Regulatory affairs and quality management spend time on points that are already documented.
Keep product and evidence knowledge available
Which evidence belongs to which product revision is knowledge held by a few individuals. When a requirement changes or staff move on, restoring that link takes real effort.
AN ILLUSTRATIVE PROCESS
From customer requirement to a substantiated product assessment
Technical sales, product management, service, and regulatory affairs bring requirements, product attributes, and existing evidence together.
Review customer needs and criteria
The inquiry contains technical, clinical, hygiene, and commercial requirements. Sales and product management determine which devices or systems are viable candidates and which departments need to be involved.
Capture criteria and assign them to departments
Requirements from criteria catalogs, attachments, and supplementary specifications are transferred into working lists. Questions on product properties, reprocessing, service, and regulatory evidence go to the respective owners.
Review products and evidence
The departments compare the requirements against product documentation, test reports, and released information. They assess which configuration is suitable, which evidence is on file, and where further clarification or testing is needed.
Align open questions and scope
Open items are clarified with the customer and, where relevant, with suppliers. Accessories, integration, training, and service are agreed. New information has to be carried into the product assessment and the planned responses.
Release responses and preserve the product reference
The responses are reviewed by the specialists and combined with the matching evidence. If something changes later, it has to be traceable which product revision and which document version the original assessment referred to.
A dependable response comes from bringing together product knowledge and evidence from several departments and documentation revisions.
WITH DECOTA
What improves for your team
Spot requirements and contradictions earlier
DECOTA captures the criteria from the catalog, the attachments, and supplementary specifications and links each one to its source passage. Open items and contradictory statements surface before the response is drafted.
Verify technical statements traceably
For every criterion you can see which product attribute and which piece of evidence covers it and which document revision that refers to. The technical assessment stays with regulatory affairs and quality management.
Reuse reviewed assessments
DECOTA recognizes recurring criteria across procedures and suggests the reviewed assessment from earlier inquiries. Your specialists confirm or correct it rather than researching from scratch.
FOR DECISION MAKERS, IN SHORT
Your product specialists spend less time on repeat questions. Sales and product management draw on information that has already been reviewed and on the evidence stored with it. When specifications change, it is easier to pinpoint which documented product revisions are affected.
Frequently asked questions
We supply group purchasing organizations with many similar inquiries. Is this especially worthwhile for us?
Recurring requirements are a good starting point for reuse. DECOTA suggests matching, already validated content from earlier inquiries. Your team checks whether it still holds for the product in question and the current conditions. How much effort that saves is something we assess against your own cases.
How current are product attributes and evidence in DECOTA?
How meaningful the results are depends on the specifications, product revisions, and evidence you have stored. Once a changed specification is reflected in the knowledge base, DECOTA supports the review of the documented links. Your specialists assess the impact and update the related assessments and evidence.
Does DECOTA make statements about a product's regulatory approvability?
No. DECOTA brings requirements, product attributes, and available evidence together and shows where evidence is missing. The regulatory judgment and every approval decision rest with your specialists.
Where can DECOTA take pressure off your team
In a first 30-minute conversation we learn how you work today, examine where DECOTA fits, and assess together what value it can deliver for your team.
Schedule a conversation