Certify faster. Prove every step.
One secure workspace where notified bodies, consultants, manufacturers and suppliers reach compliance faster, with every step on record.
Every certification hour must now be documented.
Under Implementing Regulation (EU) 2026/977, notified bodies record the time spent on each certification task, excluding the manufacturer’s time to prepare the dossier and answer non-conformities. The rules apply to agreements signed from 25 February 2027.
Work must be organised so there are at most three rounds of non-conformities, and every legitimate pause must be justified on record.
Defined digital events stop and restart the time counter when non-conformities are issued and rectified. You see who did what, and when — ready for your designating authority.
You have until February 2027 to be ready. Start a pilot now and run live certifications on the new rules before they apply.
25 Feb 2027
Quotations, maximum timelines and clock-stops (Arts 1–3)
25 May 2027
Monitoring system (Art 4(1)–(3))
25 Nov 2027
Re-certification (Arts 5–7)
1 Jan 2028
Annual public reporting (Art 4(4))
One workspace for every party in the compliance chain.
Notified bodies
Annex VII-ready certification. Every hour on record.
Regulatory consultants
Take on more clients. Keep every dossier in one workspace.
Manufacturers
From 3,000 documents to a review-ready dossier.
Supplier assessment & data collection
Qualify suppliers once. Keep them compliant every year.
One system of record for compliance, due diligence and reporting
Replace PDF questionnaires, spreadsheets, SharePoint and email with one place for your assets, certifications, compliance documentation and reporting — connected to everyone you work with.
01
Your suppliers
Perform continuous supplier assessment and/or collection of compliance data.
60%reduction in elapsed time
02
Your organisation
Consistent compliance management and reporting across the organisation.
20–50%less time spent on reporting and evidence assessment
03
Your auditors, assessors and consultants
Efficient audits, due diligence and certifications.
50%less time on evidence preparation and assessment
04
Your customers and stakeholders
Gated, AI-enabled self-service access to company and product documentation, certifications, data and self-assessments.
20–50%less time on answering customer questionnaires
05
Efficient audits and due diligence
Distribute requirements, perform the independent assessment and monitor results across your portfolio.
50%less time on evidence assessment
Four pillars of faster compliance, on a foundation of trust.
Collaborate
Secure data rooms for all parties
60% time saved on document exchange
Accelerate
AI reads and checks; people decide
80% efficiency gain on QMS assessment
Prove
Every step, decision and change on record
Full audit trail
Sustain
Stay compliant as rules change
Changes only, year on year
Medical Device Certification- UKAS/DAkkS AI alignment
ISO 27001 certified
GDPR compliant- All data hosted in the EU
DNV, one of the largest notified bodies, uses ComplAi for all its medical device certification.
- 60% time saved on document exchange and collaboration
- 80% efficiency gain assessing QMS documentation
“Seamless collaboration saved 60% of my time minimising email and document exchanges.”
See it on your own work.
Book a demo and we walk you through ComplAi on a case like yours — or start with the pre-flight check: upload your policies and see where your documentation covers the standard, and where it does not, before the auditor does.