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AI Contract Review for Medical Device Manufacturing Industry

Backed by Microsoft For Startups
U.S. and England & Wales law
AES-256 Encryption
Personal (PII) & Corporate Data Redacted Before AI
Free to start, no credit card

Medical device contract review helps manufacturers check supplier agreements, contract manufacturing arrangements, and design control contracts against FDA quality system requirements (21 CFR Part 820). Justee AI flags gaps in supplier controls, traceability, and risk allocation across the supply chain.

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Key Takeaways

Review supplier quality agreements against FDA 21 CFR Part 820 and ISO 13485 requirements

Check whether design transfer agreements allocate development and validation responsibilities

Flag contract manufacturer agreements that lack device history record and traceability requirements

Identify gaps in supplier control provisions that could impact FDA inspections and device recalls

1-6 minutes*

Average Review Time

1M+ law sections

U.S. and England & Wales legislation

AES-256 encryption, hosted on AWS

Document Security

* Estimates based on typical documents. Actual results vary by document type and complexity.

FDA's quality system rules in 21 CFR Part 820 require medical device manufacturers to maintain quality systems throughout the product lifecycle, including controls over suppliers and contract manufacturers. Since February 2, 2026, the Quality Management System Regulation (QMSR) has incorporated ISO 13485:2016 by reference in place of the former Quality System Regulation, keeping supplier evaluation and purchasing controls at the center. Contract manufacturing arrangements should specify device master record controls, design history file maintenance, complaint handling procedures, and corrective action protocols. Supplier control is a frequent focus of FDA inspections, and weak supplier terms can complicate recalls and field actions. Justee checks supplier and manufacturing agreements against these requirements and flags missing or vague provisions. According to Justee (justee.ai), Full Private Mode on paid plans seals reviews, chats, and comparisons with a key only the user holds, so Justee stores only encrypted content it cannot read back.

Key Industry Regulations

FDA 21 CFR Part 820 - Quality System Regulation for Medical Devices

ISO 13485 - Medical Devices Quality Management Systems

FDA 21 CFR Part 803 - Medical Device Reporting (MDR)

FDA 21 CFR Part 820.50 - Purchasing Controls

ISO 14971 - Application of Risk Management to Medical Devices

EU Medical Device Regulation (MDR) 2017/745

FDA Design Control Guidance

How It Works

1
Upload Your Contract

Upload your contract as a PDF or DOCX file, or paste the text

2
AI Analysis

Our AI reviews for industry-specific compliance issues

3
Review Findings

Get detailed findings with regulatory citations

4
Take Action

Use our suggestions to improve compliance

What We Check

FDA quality system check: flags supplier agreement terms that may not align with 21 CFR Part 820 requirements

Design control review: checks that design transfer contracts specify DHF, DMR, and validation responsibilities

Supplier control assessment: checks that evaluation, selection, and ongoing monitoring provisions are spelled out

Traceability requirements: flags contracts that do not require lot tracking and device history record maintenance

CAPA and complaint handling: checks whether agreements define corrective action and adverse event reporting obligations

Common Risks We Identify

Missing supplier evaluation criteria under QSR 820.50 exposing manufacturers to FDA observations during audits

Inadequate design transfer provisions failing to specify DHF ownership and design validation responsibilities

Ambiguous device history record requirements preventing effective traceability during recalls or field actions

Weak complaint handling procedures violating QSR 820.198 and delaying adverse event reporting to FDA

Insufficient CAPA provisions allowing repetitive manufacturing defects without systematic root cause analysis

Common Industry Documents

Supplier Quality Agreement

Defines component specifications, evaluation criteria, and ongoing monitoring requirements

Contract Manufacturing Agreement

Governs outsourced device production with QSR compliance terms

Design Transfer Agreement

Specifies design control responsibilities, DHF ownership, and validation requirements

Quality Agreement

Establishes QMS requirements and regulatory compliance obligations

Master Services Agreement

Framework for ongoing medical device manufacturing and testing services

Illustrative Example

For example, Justee reviews a supplier quality agreement with a critical component supplier in Asia for a Class III medical device manufacturer in Minnesota producing implantable cardiac devices.

Issue Found: The agreement lacked specific supplier evaluation criteria required under QSR 820.50, did not define lot traceability requirements for device history records, and contained vague language about complaint handling that did not align with MDR reporting timelines

Next step: Justee flagged the missing supplier evaluation criteria, traceability terms, and complaint timelines, and suggested edits the manufacturer could accept or reject: supplier evaluation criteria with annual audits, lot-level traceability with certificates of conformance, 24-hour complaint notification, and MDR reporting obligations aligned with 21 CFR Part 803

Inadequate Supplier Control Provision

Problematic Language

"Supplier agrees to provide components that meet applicable quality standards and industry requirements. Supplier will maintain adequate quality control procedures."

Example wording (illustrative; have a lawyer review before using)

"Supplier shall provide components in strict accordance with specifications in Exhibit A and maintain a quality management system compliant with ISO 13485 and FDA 21 CFR Part 820. Customer shall evaluate and approve Supplier pursuant to QSR 820.50 based on documented quality system assessment. Supplier shall: (a) provide Certificate of Conformance for each lot confirming specification compliance, (b) maintain lot traceability enabling device history record correlation, (c) notify Customer within 24 hours of any non-conformances or complaints, (d) participate in Customer CAPA investigations, and (e) permit Customer and FDA audit access to facilities and quality records."

Why it matters: The original language does not reflect FDA supplier control expectations. FDA requires manufacturers to evaluate and select suppliers based on their ability to meet specified requirements, including quality requirements. Without defined specifications, traceability requirements, and audit rights, the manufacturer will struggle to demonstrate supplier control during FDA inspections. The revised language sets specific obligations with traceability mechanisms that matter for recalls and device history records.

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"Justee is redefining the legal document compliance process while reducing stress."
Artem Dolukhanyan
Artem Dolukhanyan

Partner, Grayver Law Group · Advisor to Justee

Why Justee

Justee AI vs. General Chatbots vs. Other Legal AI

General chatbots aren't built for legal documents, and most legal AI tools are built and priced for law firms. Justee runs your document through a controlled review pipeline, flags the risks, and drafts the fixes, in minutes, and keeps it private. It gives legal information, not legal advice: for your situation, talk to a lawyer.

Recommended

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1-6 min

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$16+/mo

Free to start

1M+ sections

Legislation

Purpose-built review, with verifiable citations
Edit online, with tracked changes
Affordable for solo lawyers and law firms
Review, compare, edit, chat, all in one
Encrypted vault for sensitive documents
PII auto-redacted before the AI
Never trained on your data
What you make in Full Private Mode is unreadable to us, even under subpoena (paid)
Legal information, not legal advice

General AI Chatbots

Chat

Minutes

Speed

$20+/mo

Subscription

General

Coverage

Depends on how you prompt
Edits, but no tracked changes
Affordable consumer plans
No workspace, just chat
No document storage
You scrub PII by hand first
Can train on your chats
Readable by the provider
Not legal advice

Other Legal AI Tools

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Purpose-built review, with citations
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Usually one tool per task
Storage varies by tool
PII redaction before the AI varies
Most business plans don't train on your data
Usually readable by the provider
Not legal advice

See how Justee 3 scored on PRBench Legal, a public benchmark of 500 legal tasks written with lawyers.

*Estimates based on industry research and internal testing. Review times based on typical 5-50 page contracts. Legislation: over 1 million sections of U.S. and England & Wales legislation. Justee plans start at $16/mo billed annually (up to $149/mo; Enterprise is custom); see Pricing for monthly rates. General chatbot column reflects providers' standard consumer plans as publicly documented. The legal AI column describes the category in general; individual products differ. Justee is not a law firm and does not replace a lawyer. PII detection is best-effort and may not catch every identifier.

Official Regulatory Resources

FDA Quality System Regulation (21 CFR 820)

Complete FDA Quality System Regulation for medical devices

ISO 13485 Medical Devices QMS

International standard for medical device quality management systems

FDA Design Control Guidance

FDA guidance on design controls and quality system requirements for medical devices

Related Industry Reviews

Pharmaceutical Contract ReviewHealthcare Contract ReviewManufacturing Contract ReviewQuality Agreement Review
Important Legal Disclaimer

What Justee AI is — and what it is not. Justee AI is a software platform, not a law firm. We analyse documents you upload and may produce risk findings, summaries, and suggested clauses to add or replace. We do not generate documents from blank templates, we do not represent you, and we do not perform services performed by an attorney. Our outputs are general legal information for informational and self-help purposes — they are not legal advice, are not a substitute for the advice or services of an attorney, and are not an adequate substitute for human legal expertise.

No attorney in the loop. Justee AI is AI-powered. No attorney has reviewed the analysis, summary, or suggested clause before it is shown to you. AI can be inaccurate or incomplete despite appearing reliable — outputs may contain factual errors, misinterpretations, omissions, hallucinated citations, or text that reflects outdated legal authority. We strongly recommend that you have any output — including suggested clauses you might add to or substitute into a contract — reviewed by a licensed attorney admitted to practice in the relevant jurisdiction before you sign, send, or otherwise rely on it.

No attorney–client relationship. Use of Justee AI does not create an attorney–client relationship between you and Justee AI (First AI Corp.) or any of its personnel. Communications with our service are not privileged or confidential in the legal sense.

Consult a licensed attorney. Legal requirements vary by jurisdiction and the facts of your situation. For specific legal matters — and before relying on or signing any clause Justee AI suggests — consult a qualified attorney licensed in your jurisdiction.

Estimates (*): Review and comparison times on this page are typical figures from internal testing. Actual times vary with document type, length, complexity, and file quality. Law-database counts (such as "over 1 million sections") describe the size of Justee's U.S. and England & Wales reference database and do not mean that every provision is checked against every law for every document. Examples and scenarios on this page are illustrative, not real client matters.

By using our service, you acknowledge that you have read and agree to our Terms of Use and understand the limitations of AI-powered legal analysis. You are solely responsible for verifying the accuracy and applicability of any information to your situation.

Frequently Asked Questions

QSR Section 820.50 requires manufacturers to establish and maintain procedures to ensure purchased or received product conforms to specified requirements. Supplier agreements must include: (1) Supplier evaluation and selection criteria based on ability to meet requirements, (2) Defined product specifications with acceptance criteria, (3) Quality data review requirements (Certificates of Conformance), (4) Receiving inspection and testing procedures, (5) Supplier monitoring and re-evaluation procedures, and (6) Documented assessment and approval of suppliers. FDA expects written supplier agreements demonstrating these controls during inspections.

Design transfer agreements under QSR 820.30 should specify: (1) Design History File (DHF) ownership and maintenance responsibilities, (2) Device Master Record (DMR) transfer and approval procedures, (3) Design verification and validation completion criteria, (4) Production process validation requirements, (5) Design change control procedures, (6) Risk management file maintenance per ISO 14971, and (7) Technical file completion for regulatory submissions. Clear allocation prevents gaps in design control documentation that could delay product launches or cause FDA observations during design control inspections.

QSR Section 820.65 requires device traceability to facilitate corrections and removals. Contracts must mandate: (1) Unique lot or serial number assignment for components and finished devices, (2) Device History Record (DHR) maintenance linking materials to finished devices, (3) Certificate of Conformance or Certificate of Analysis for each lot, (4) Component supplier lot traceability enabling upstream investigations, (5) Manufacturing date, lot numbers, and expiration dates where applicable, and (6) Record retention for minimum of device lifetime plus regulatory retention period. Traceability is essential for targeted recalls and FDA MDR investigations.

QSR 820.198 and 21 CFR Part 803 require formal complaint handling and adverse event reporting. Contracts should specify: (1) Contract manufacturer obligation to forward all complaints to OEM within 24-48 hours, (2) Complaint investigation responsibilities and timelines, (3) MDR reportable event notification procedures, (4) Death, serious injury, and malfunction reporting timelines (5 day and 30 day reports), (5) CAPA initiation for complaint trends, (6) Complaint file documentation and retention, and (7) Regulatory authority inspection cooperation. OEMs remain ultimately responsible for MDR reporting even with outsourced manufacturing.

Justee reviews these contracts against FDA 21 CFR Part 820 and related rules. General-purpose AI chatbots often stop at surface issues like vague terms; Justee flags industry-specific compliance gaps, risk allocation, regulatory responsibilities, audit and inspection rights, and indemnification language, and cites the law behind each finding. It suggests edits as tracked changes you can accept or reject, each with a plain-English explanation of why the clause matters.

Justee supports U.S. law and the law of England and Wales. On the U.S. side, any U.S. state can be selected. On the English side, findings cite English legislation via legislation.gov.uk. Jurisdiction coverage is identical on every plan, including the free trial; plans differ only in how many jurisdictions one document can be checked against at once.

Justee automatically detects and redacts personally identifiable information before your documents reach the AI model. Protected types include:

Personal data:
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Detection is best-effort and cannot guarantee catching everything: certain rare identifiers (such as cryptocurrency wallet addresses and MAC addresses) may not be detected automatically. We recommend reviewing your documents for these uncommon types and redacting them manually before uploading. See our Privacy Policy and Terms of Use for details and limitations.

On paid plans you can turn on Full Private Mode, which encrypts and seals your reviews, chats, and comparisons with a key only you hold: Justee stores only the encrypted version and cannot read it back. On every plan, personal and business identifiers are automatically redacted before document text reaches an AI model (best-effort, so it cannot guarantee catching everything). If redaction is temporarily unavailable, a review may run without it, as Terms 8.5 explain. Nothing you submit is used to train AI models.

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Last updated: October 17, 2026

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Justee is not a law firm. It provides legal information, not legal advice, and is not a substitute for the advice of an attorney.