EU MDR 2017/745 FDA
ISO 10993-1:2025 · Biological Evaluation Review and Remediation

Biological safety documentation review and remediation
done in a few hours.

Klaris reviews your documentation against ISO 10993-1:2025. Every gap cites a clause and a fix, for both EU MDR 2017/745 and FDA.

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aurion_npwt_v3.1 · BEP + BER · Biological Evaluation review Klaris report
CLASSIIb · NPWT system
CONTACTBreached skin · cumulative 14 d
2Not Satisfied 3Partially Satisfied 15Satisfied
BEP 8 / 11 Satisfied
BER 7 / 9 Satisfied
See a sample gap
GAP 01 OF 5 NOT SATISFIED ISO 10993-1:2025 · § 6.4

REQUIREMENT

"Contact duration shall be determined on the basis of the cumulative time the device or material is in contact with the patient, not the duration of a single exposure event."

EVIDENCE IN FILE

BEP · § 2.3 · PAGE 6

"Each dressing remains in contact with the wound bed for approximately 8 hours; exposure duration is therefore classified as limited (< 24 h) per ISO 10993-1:2018 Table A.1."

→Klaris suggests
  1. Recategorize exposure as prolonged-to-long-term under § 6.4 of ISO 10993-1:2025: a 14-day treatment course is cumulative, not per-dressing.
  2. Recompute the biological-effects panel for the new category; additional biological effects become in-scope.
  3. Update the BEP § 2.3 rationale to cite the 2025 edition and the cumulative-contact rule; align the BER conclusion accordingly.
Built by experts Curated by senior regulatory experts & former Notified Body reviewers.
EU data residency Resides in the EU (Belgium); managed in the EU and UK.
Any risk class Supports any medical device, regardless of risk class.
Security first ISO/IEC 27001:2022 certified. Zero data retention.
Klaris works while you sleep

You work on high leverage.
Klaris does the heavy lifting.

Klaris reads every line, cross-checks every document, matches each section to a clause, and writes every gap assessment and remediation, in parallel. Most reviews come back in a few hours.

01 Standard analysis

Our experts analyzed the standard for you.

YOUR TIME · ONE-TIME
~5 weeks None
02 Document review

Klaris reviews page by page and clause by clause.

YOUR TIME · PER DEVICE, EVERY REVIEW
~1 week None
03 Decide & Remediate

You decide which gaps to close, and how.

YOUR TIME · PER DEVICE, EVERY EDIT CYCLE
~2 weeks ~1 week
Experts in the loop

Not hallucinated. Built by experts who have drafted (and rejected) BERs.

The requirements behind every Klaris review are authored by experts with decades of practice: consultants, manufacturers, and Notified Bodies. They are not extracted by a large language model. Here's the panel that built the requirements behind Klaris.

BIOTECHNOLOGY · MANUFACTURER PERSPECTIVE

Chiara Lorenzetto

Chiara Lorenzetto

Decades of experience in the medical device industry and dozens of approved medical devices across the EU and US.

Read Chiara's take
"With Klaris running the line-by-line gap-finding, I can focus primarily on the strategic regulatory work that my clients look for, and integrate my expertise in the field with the automated cross-referencing against the standard that Klaris does."
FOUNDER · NIUCONS CONSULTING
ADVISOR & ANGEL INVESTOR, KLARIS

CHEMISTRY · NOTIFIED BODY PERSPECTIVE

James Ward, PhD

James Ward, PhD

Reviewed hundreds of devices and inspected manufacturers globally. Previously Principal Technical Specialist and Decision Maker (Panel Member) at BSI.

Read James's take
"The thoroughness catches the issues I would have flagged in a full assessment, before the documentation reaches a reviewer. That leaves the review focused on what actually matters: patient safety and the judgment calls only a human should make."
EX-BSI PRINCIPAL TECHNICAL SPECIALIST AND DECISION MAKER (PANEL MEMBER)
KLARIS REGULATORY LEAD

REGULATORY & LEGAL · CONSULTANT PERSPECTIVE

Marisa Testa

Marisa Testa

20+ years of experience in EU, US, and international regulatory affairs for the medical device industry, including FDA submissions.

Read Marisa's take
"A generic regulatory expertise is not enough to assess the biocomp requirements. With Klaris a super specific and detailed gap-analysis is the must-have first step to get things done. And ready just in an afternoon!"
FOUNDER · THEMA
ADVISOR & ANGEL INVESTOR, KLARIS
Why Klaris

Purpose-built for regulatory compliance.
Not for sounding like it.

  • ISO 10993-1:2025 was published in November 2025, so a generic AI is trained on the 2018 edition and confuses clauses across editions. FDA also recognizes specific revisions of each part in its CDRH database, each with an extent of recognition, and the latest ISO release is not always recognized yet.

    • Klaris experts map every clause on the new edition; the library is versioned and locked to the edition you're submitting against
    • Locks to the FDA-recognized revision for the US section and the latest ISO edition for the EU file
    • Tracks recognition status and transition deadlines from the CDRH database, and flags where the ISO panel and FDA guidance diverge

  • A gap is only useful if the clause it cites actually says what you think. Generic AIs hallucinate clauses that look plausible, then hand back a black-box verdict. A gap you can't defend is a gap you can't submit.

    • Every gap links to a requirement authored by a senior expert; Klaris matches your text and never invents requirements
    • Cites the exact passage, page and clause, with end-to-end traceability across biological safety documentation, risk management documentation and IFU
    • Explains each judgment in plain language a reviewer can follow and a PRRC can sign

  • Biocompatibility requirements depend on the device's category, contact type, and duration. A generic checklist over-tests on some biological effects and misses others.

    • Scopes the requirement set to your device's category, contact type, and duration
    • Shows why each requirement applies, traced to § 6.4 and the contact-tissue tables
    • Flags the requirements that don't apply, with the reason

  • A generic AI is non-deterministic. Ask twice, get two different gap lists, and no human stands behind the output. A submission needs a review you can reproduce, defend, and escalate to a person.

    • Versioned requirement library locked per run; identical inputs produce identical gaps
    • Re-run after every edit with no unexplained drift
    • Reach out on any gap; our expert(s) can counter-sign the deliverable and your in-house experts can accelerate the work

  • Technical documents, unpublished devices, clinical data: your IP cannot become someone's training set. Pasting a BER into a consumer chatbot puts it in their dataset by default.

    • Zero data retention, contracted in writing with major model providers
    • Documents are never retained or used for training by model providers or by us
    • EU data residency, ISO/IEC 27001:2022 certified
Pricing

From £1,000 per device.

Choose who signs off on the output, your team, or ours.

YOU SIGN OFF

Klaris + Your Experts

For in-house experts, or consultants running their own reviews. Klaris does the heavy lifting. You stay in the loop on every gap and remediation.

£1,000 / device
Portfolio discount for 3+ devices.
See all 7 features
  • Full AI gap analysis against ISO 10993-1:2025
  • EU MDR and FDA, same per-device price
  • Cross-document consistency check (BEP ↔ BER ↔ risk file ↔ IFU)
  • Specific remediations, traced to each gap and clause
  • 10 iterations included: re-submit until clean
  • Turnaround in hours
  • Structured report with every gap clause-cited
Start with Klaris + Your Experts
WE SIGN OFF

Klaris + Our Experts

When you want the report counter-signed by a human, or need extra help on anything biological evaluation related. Our experts are ready to help.

Custom
Quoted by device family and expert hours.
See all 7 features
  • Everything in Klaris + Your Experts
  • Independent blind review by a senior reviewer
  • Human-authored overall report and remediation roadmap
  • Strategy advice on classification
  • Biological-effect testing panel design
  • Equivalence-claim review
  • Direct line to the reviewer during remediation
Request a quote

Billed in GBP; we apply the conversion at billing time.

  • Fewer review cycles, NB or FDA.

    Every gap caught before submission is one less round of questions, a Notified Body query before your CE mark or an FDA deficiency letter before clearance.

  • Hours, not months.

    A consultant biocomp review runs 2 to 6 weeks at around £200 an hour. Klaris delivers the same coverage overnight for the flat fee, then re-runs as often as you need.

  • Flat fee, 10 iterations.

    £1,000 per device covers a review of the biological safety documentation and 10 review iterations across drafts and post-edits, valid 6 months from kick-off. Predictable, no hourly meter.

Developed with

High-risk device manufacturers
running the 10993-1:2025 transition with Klaris.

ORTHOPEDICS CLASS IIb · IMPLANT

Bioceramic implants

Klaris flagged a categorization mismatch our team had missed, two weeks before submission. With the clause cited, it was a five-minute fix instead of a debate.

Regulatory Manager · orthopedic implants
CARDIAC SURGERY CLASS III · IMPLANT

Bioprosthetic heart valves

It caught a drift between our BER and IFU that a Notified Body would have raised in week three. We fixed it before they ever saw the file.

Regulatory Manager · cardiac surgery

Want to hear it from a peer? We'll connect you with a regulatory lead who has used Klaris, book a demo.

How to get started

Three steps to your first review. Sign, configure, upload.

No portals to integrate, no procurement marathon. Sign the engagement letter, configure your workspace with us, then drag and drop your file. Resubmit as often as you need.

  1. 01 · SIGN

    Engagement letter.

    Sign digitally, same day. Standard mutual NDA available on request.

    Same day · digital signatures
  2. 02 · CONFIGURE

    Kick-off call.

    We walk through your device characteristics. Your secure workspace is provisioned at the end of the call.

    ~30 min · with a specialist
  3. 03 · UPLOAD

    Drag and drop, anytime.

    Drag your documentation into the portal. Iterate freely across drafts and post-edits until your documentation is ready.

    ~5 min · per submission
One more thing

An inconsistent intended-use claim between the BER and the IFU is a finding waiting to happen. Here's what it looks like in Klaris.

CONSISTENCY REVIEWER · SUBMISSION 02 · TUE 03:14 INCONSISTENCY FOUND
BER · § 4.5 · PAGE 18 BIOLOGICAL EVALUATION
"Device contact duration is limited to 30 days; biological evaluation conducted accordingly per ISO 10993-1:2025 Annex A.2 (limited exposure)."
IFU · § 2.4 · PAGE 8 INTENDED USE
"Device may be implanted for periods extending to 90 days post-operatively based on attending physician's clinical assessment."
Klaris flagged this.
Why this matters The 90-day implantation in the IFU pushes the device from "limited" to "long-term" contact, under ISO 10993-1:2025 Annex A.2 (your Notified Body) and under FDA's 2023 guidance Attachment A (your FDA reviewer). Both now expect chronic toxicity (ISO 10993-11:2017) and implantation (ISO 10993-6:2016) biological effects absent from the BER. The same drift surfaces as an FDA letter on biocompatibility scope, adding a review cycle before clearance. Suggested fix: align BER § 4.5 duration with IFU clinical scope, or restrict IFU scope.

Klaris Consistency Reviewer

Catch cross-document drift before the NB, or the FDA reviewer, does.

Klaris compares claims from the IFU, SSCP, and 510(k) §G.5 against the biological safety documentation before the reviewer asks. Works for any document, EU or FDA.

See the Consistency Reviewer
Ready to ship?

Catch every gap
before your reviewer does.

Submit your documentation and Klaris drafts every remediation in hours, ready by morning if you run it at end of day.

Start your review Book a demo
FAQ

Before your first review with Klaris, what teams want to know.

What does the £1,000-per-device engagement actually cover?

One device family per engagement (variants included). All biological safety documents covered together. 10 review iterations included, valid for 6 months from kick-off. Re-submit across drafts, post-edits, supplier changes, or after a Notified Body question. Portfolio discount available for 3+ devices.

Can Klaris review my whole Technical Documentation, not just biological safety documentation?

Yes. Klaris reviews the full Technical Documentation package per MDR 2017/745 Annex II. Whole-TD engagements are priced per scope. FDA 510(k) coverage is on the roadmap.

Which ISO 10993-1 revision does Klaris use for an FDA submission?

ISO 10993-1:2025. FDA recognized the 2025 sixth edition in May 2026 (a partial recognition, RN 2-313); declarations to the 2018 fifth edition stay acceptable until 1 July 2029. Klaris reviews against the 2025 revision.

How does Klaris avoid hallucinated citations, and are reviews reproducible from one submission to the next?

Every gap links back to the clause definition that triggered it (authored by a senior expert, dated and versioned) and to the exact text in your document it was anchored to. Klaris' job is to match your text to a clause definition an expert already wrote; it does not decide what a clause means at review time. You get the same gaps for the same documents.

Does Klaris train AI on my data?

No. Klaris has a strict zero-data-retention policy contracted in writing with every model provider in our stack. Your documents are never used to train any model.

How does Klaris secure my data?

Klaris is ISO/IEC 27001:2022 certified, third-party audited against an independent information-security management system. Documents are encrypted in transit and at rest, live only for the duration of the review, and are never used to train any model. The full register of controls and sub-processors is published at trust.klaris.ai.

Is Klaris GDPR compliant?

Yes. Data is processed in EU/UK regions only. Data Processing Agreements are available on request.

What file formats does Klaris accept?

PDF, DOCX, and XLSX. Drag and drop any documentation into the Klaris workspace. No special formatting, no templates to fill in.

Klaris Insights

By our experts, the most useful regulatory insights.

Clause-by-clause reads on the standards and guidance shaping MedTech submissions, from the experts behind the Klaris requirement library.

ISO 10993-1:2025: what changed, and how to retrofit your documentation.

The five structural changes in Edition 6, what each looks like in a 2018-era file, and how to bring it in line, for your Notified Body and your FDA reviewer.

Read the deep dive