Based on hundreds of real buyer-seller diligence conversations we’ve helped happen on Rejigg, these are the medtech topics that decide whether a buyer believes your device can keep shipping, keep getting paid for, and stay compliant after close.
Each topic below comes from real buyer-seller conversations. Here's what they ask, what they're really evaluating, and how to prepare.
Claims & Status
Buyers are sizing up stop-ship risk. They want proof that your website, labeling, sales decks, distributor listings, and rep scripts stay inside your cleared or registered use, or that you have a defensible reason for how you sell today. If you can’t show that line clearly, they assume enforcement risk and product liability exposure, even if nothing has happened yet.
How to prepare
Great Answer
We maintain an SKU-by-SKU claims-to-support sheet. For each sales channel, it shows the exact claims language, the supporting label or clearance, and the person who approves any change. We audit distributor materials twice a year, and this year we removed two slides that drifted into clinical language within 48 hours.
Okay
We’re cleared for our main intended use, and we try to keep materials aligned, but we haven’t documented it by SKU yet.
Gives Pause
We’ve never had trouble with FDA, and marketing is marketing. We say what customers want to hear.
How Rejigg helps: Rejigg’s buyer vetting and digital NDAs let you share a claims-to-support pack with serious buyers before anything leaks outside diligence. Learn more in the guide
FDA Pathway
They are underwriting regulatory timeline risk and whether your growth plan triggers a new submission, a new test, or a pause in sales. This gets pointed with RUO (Research Use Only) products because the buyer will test whether revenue is being driven by clinical use while the company looks away. They also want a clean narrative on inspections, significant quality events, and what changed afterward.
How to prepare
Great Answer
Here’s our pathway timeline with dates and outcomes, including two labeling updates and one additional information request that we closed in 38 days. Our roadmap includes three planned changes, and we’ve flagged which are documentation-only versus likely to require new testing and an updated submission. For RUO, we have documented labeling and content review, and we declined two customer requests for clinical claims in writing.
Okay
We’re cleared today, and we don’t expect issues, but we haven’t mapped future changes to regulatory impact yet.
Gives Pause
We’ll figure out FDA later. We’ve been selling for years, so it’s probably fine.
How Rejigg helps: Rejigg’s secure data room keeps your pathway timeline, key correspondence, and change-impact plan together so a buyer’s regulatory team can review without email sprawl. Learn more in the guide
QMS Reality
Buyers are looking for proof that quality work happens when nobody is watching. They want to see complaint handling, investigations, corrective actions, training, audits, and management review operating as a routine, not a scramble right before an audit. A spotless log often reads like under-reporting, so be ready to explain your thresholds and your process.
How to prepare
Great Answer
We can show three full threads from the last 12 months, including one that drove a process change and a verification test before release. Here are monthly complaint trends, our top three failure modes, and our average close time, which is 21 days this quarter versus 34 last year after we changed triage ownership. We also have internal audit findings with documented closures and management review notes with specific action items.
Okay
We have a QMS (Quality Management System) and can show CAPA (Corrective and Preventive Action) and complaint logs, but we haven’t packaged trend views or end-to-end examples yet.
Gives Pause
Quality is fine. We pass audits when they happen and don’t really get complaints.
How Rejigg helps: Rejigg’s built-in data room lets you share controlled QMS evidence, including logs, samples, and trend charts, in a format buyers can actually review. Learn more in the guide
Change History
In medical devices, uncontrolled change is where diligence bogs down because it can break prior testing assumptions, labeling support, and manufacturing readiness. Buyers want confidence they can maintain and improve the device without discovering undocumented design drift. A clear change summary usually speeds diligence up because the buyer doesn’t have to reconstruct your history from raw files.
How to prepare
Great Answer
We have a DHF summary that ties requirements to verification, plus a change log for the last 30 months with the reason for each change, the risk assessment, and the verification we ran before release. We have two in-flight changes with owners and planned verification dates. If you want to go deeper, we can open the underlying DHF files in a second access phase.
Okay
We have the DHF and change records, but we haven’t summarized them, so it takes time to walk through.
Gives Pause
We’ve made a lot of tweaks over the years. The engineers know what changed.
How Rejigg helps: Rejigg’s permissioned data room lets you share a DHF and change-history digest first, then expand access only when the buyer is truly engaged. Learn more in the guide
Labeling & UDI
They want to see traceability and revision control because labeling errors and identifier mismatches can turn into costly field actions, even when the device performs fine. UDI touches packaging, systems, and customer requirements, so gaps here can become liabilities on day one after close. Buyers look for proof you can identify affected lots, versions, and customers quickly and reliably.
How to prepare
Great Answer
Label changes go through a documented approval workflow with QA sign-off, and our release checklist includes scrapping old label stock. We can trace a finished unit from supplier lots through shipment and generate an affected-customer list in under an hour. For UDI, we can show where it’s generated, how it’s applied on packaging, and how we maintain the database records.
Okay
We track lot and serial numbers and keep labels under document control, but our traceability report isn’t automated yet.
Gives Pause
We update labels when needed. If there was an issue, we’d figure it out.
How Rejigg helps: Rejigg’s data room gives buyers a structured path through labeling control and traceability evidence, without turning diligence into endless back-and-forth. Learn more in the guide
Manufacturing Controls
Buyers are judging whether you can consistently stop bad product from shipping and whether your output is transferable to a new owner. They will dig into incoming inspection, calibration, acceptance criteria, rework rules, and what you do when yield drops. If production depends on tribal knowledge or a contract manufacturer’s undocumented process, they will price in disruption risk.
How to prepare
Great Answer
Here’s our manufacturing walkthrough with each inspection gate, the acceptance criteria, and the sign-off owner. We track yield and rework by month and can point to the step that drove most rework, plus the fixture change that reduced it by 40%. For our contract manufacturer, we have a quality agreement, an audit schedule, and a documented process for nonconforming material and corrective actions.
Okay
We can explain how we build and test the product, but our metrics are scattered across systems and people.
Gives Pause
We build it the way we’ve always built it. The team knows what ‘good’ feels like.
How Rejigg helps: Rejigg’s data room keeps your manufacturing walkthroughs, yield trends, and supplier or CM (Contract Manufacturer) quality evidence in one place for ops and quality diligence. Learn more in the guide
Supply Chain
They are hunting for bottlenecks that cap growth, like single-source components, long-lead parts, special processes, sterilization dependencies, and tooling you do not control. In devices, supplier risk quickly turns into compliance work because a change can trigger validation and documentation updates. Buyers want a concrete plan for what happens if a critical vendor slips six weeks or disappears.
How to prepare
Great Answer
We maintain a critical-path supplier map that flags two single-source items and one special process with long lead times. For each, we list alternates and the specific qualification and validation work required to switch, including expected time and cost. We also own our tooling and test fixtures, and we can show where they’re stored and how they’re maintained.
Okay
We know our single-source parts and long-lead items, but we haven’t documented alternate qualification steps yet.
Gives Pause
We can always find another supplier if we need to.
How Rejigg helps: Rejigg helps you share a supplier risk map early so buyers can price the real risks, not worst-case guesses. Learn more in the guide
Installed Base
For many medical device businesses, the installed base drives consumables, service, upgrades, and software renewals. Buyers want to see that you can count active units with a definition that matches how service and sales operate, then break it down by customer type because hospitals, labs, DME (Durable Medical Equipment) providers, and consumers behave differently. If the data is imperfect, a transparent estimate with clear inputs usually lands better than vague confidence.
How to prepare
Great Answer
We define active as a unit with recorded usage or consumable purchases in the last 90 days. We have 1,240 active units, segmented by hospital, lab, and distributor-led sites, plus version breakdowns for the top two revisions. We can show service event rate trends and typical replacement cycles, and we use this installed-base view to drive consumables inventory planning.
Okay
We have a good sense of how many units are out there, but our activity definition and segmentation need cleanup.
Gives Pause
We’ve sold a lot of units. We don’t track which ones are still in use.
How Rejigg helps: Rejigg’s data room gives you a clean place to share installed base reports and service metrics without emailing spreadsheet versions around. Learn more in the guide
Repeat Revenue
Buyers want to understand why reorders happen and whether they survive a handoff. Recurring consumables and renewals tend to stick when they are embedded in customer workflow, like standard protocols, standing purchase orders, or a service calendar. Recurrence that relies on one rep’s reminders, bundling deals, or constant exceptions can soften after close.
How to prepare
Great Answer
We can show cohort behavior. Sites installed in 2022 reordered at 78% in 2023 and 74% in 2024, with a median reorder interval of 46 days in labs and 63 days in hospitals. Service contract renewal is 81%, and most renewals run through a scheduled procurement calendar. Where recurrence is weaker, we can show what we changed and the leading indicators that moved first.
Okay
We see repeat ordering and renewals, but we haven’t built cohort tables or reorder interval tracking yet.
Gives Pause
Recurring revenue is strong because our reps stay on top of customers.
How Rejigg helps: Rejigg helps you share cohort-based pull-through proof early so qualified buyers can get comfortable enough to make an offer. Learn more in the guide
Owner Dependence
Buyers are measuring transferability. They want to know whether quality and regulatory approvals, supplier decisions, and engineering judgment calls are spread across a team or stuck with the founder. This usually changes deal structure and price more than it kills the deal because the buyer may fund overlap and hires. A simple handoff map and a realistic transition plan reduce uncertainty quickly.
How to prepare
Great Answer
QA sign-offs are owned by our QA lead, regulatory work is owned by our RA consultant with documented templates and an internal backup, and engineering decisions are reviewed weekly by two engineers with meeting notes saved in our system. I still handle two supplier escalations and one change-approval step, and both workflows are documented. Post-close, I’m available for a six-month transition with a defined scope and a weekly handoff cadence.
Okay
Most things run without me, but a few approvals still route through me, and we haven’t documented a full transition plan.
Gives Pause
If I leave, it’ll be hard. I’m the only one who really knows the product and quality stuff.
How Rejigg helps: Rejigg’s process guidance and deal tracking help you propose and negotiate a specific transition plan, instead of leaving it open until the last week. Learn more in the guide
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What is a medical device company typically worth?
A medical device company’s value usually comes down to how “shippable” and repeatable the buyer believes it is: clear regulatory status by SKU, a quality system with real evidence, reliable manufacturing output, and repeat revenue from the installed base. Multiples vary a lot by device class, sales channel, and margin profile, so start with Rejigg’s free valuation calculator. Then sanity-check the common medtech-haircut areas, like claims drift, slow complaint closures, or single-source suppliers.
Do I need a broker to sell my medical device company?
No. Brokers usually charge 5–10% of the sale price for a process you can run yourself with the right tools. Rejigg gives you access to pre-vetted buyers, digital NDAs, a secure data room, direct messaging, scheduling, and offer tracking. It’s free for sellers because buyers pay. If you can answer the regulatory, quality, and manufacturing questions with documents to back it up, you can sell without a middleman.
How long does it take to sell a medical device company?
Most timelines depend on how quickly you can satisfy a buyer’s quality, regulatory, and operations diligence. With an organized diligence pack, many deals can move in a few months. If claims support, QMS examples, change history, or supplier controls are scattered, it often stretches much longer because the buyer has to rebuild the story. Rejigg’s prepare-to-sell guide and built-in data room help you front-load the proof that usually slows medtech deals.
What is an LOI in a medical device acquisition?
An LOI is a letter of intent. It’s a written offer that outlines price and key terms before full diligence and the final legal agreements. In medical devices, a strong LOI usually spells out what the buyer expects to confirm around regulatory status by product, quality system evidence, manufacturing controls, and any open investigations or field issues. Rejigg’s deal dashboard lets you compare LOIs side-by-side so you can see price, holdbacks, earnouts, and timing in one place.
How should I handle confidentiality when selling a medical device company?
Treat confidentiality as a real risk, especially with claims language, labeling, complaint examples, and regulatory correspondence. Use an NDA before sharing anything sensitive, and avoid emailing attachments that can be forwarded or lost. On Rejigg, buyers are pre-vetted and sign digital NDAs before they see sensitive information. You also control access by phase in the data room so you can share summaries first and open deeper files later.
Can a buyer use SBA financing to buy a medical device company?
Sometimes. SBA loans are more common for businesses with steady cash flow and low customer or product concentration, and some lenders get cautious with device companies because of regulatory and product risk. A buyer has a better shot when revenue is predictable, margins are stable, and the compliance story is clean. You can model payments and structures with Rejigg’s SBA loan calculator before you negotiate.
What financial statements do buyers expect for a medical device deal?
Most buyers ask for three years of profit and loss statements, a current year-to-date P&L, and a balance sheet that ties out. In medical devices, expect extra pressure on gross margin detail, especially rework, scrap, expediting, returns, and service costs. Those are common places where the “real” margin shows up. If you use QuickBooks, Rejigg’s QuickBooks integration can import financials and help populate your data room without hand-built spreadsheets.
What are common add-backs for a medical device company sale?
Add-backs are expenses that likely won’t continue for a new owner, and they affect the earnings a buyer uses to price the deal. In medtech, common add-backs include one-time regulatory consulting for a specific submission, unusual test lab spend tied to a discrete event, and founder travel that is not needed to run the day-to-day. Document each add-back with invoices and a plain-English explanation. Rejigg’s valuation flow helps you present add-backs in a way buyers can audit.
What is a working capital adjustment in a medical device acquisition?
A working capital adjustment makes sure the business transfers with enough day-to-day operating resources, like inventory, receivables, and payables. In medical devices, it can get messy because inventory includes long-lead components, sterile finished goods, and safety stock that protects service levels. Buyers usually expect a “normal” level at closing, based on history. Rejigg’s negotiation guide walks through how to prepare for that discussion.
How do earnouts work for medical device companies?
An earnout means part of the price gets paid later if the business hits agreed targets. In medtech, earnouts often tie to milestones like a revenue target, a specific hospital win, or launching a new version on schedule without regulatory delays. Earnouts can work, but only if the definitions are tight and the buyer’s control over pricing, sales focus, and product changes is addressed up front. Rejigg’s offer comparison tools help you compare certainty versus headline price.
What kind of transition period do buyers expect in medtech deals?
Many buyers want a real transition because the critical knowledge can sit in QA sign-offs, supplier relationships, complaint investigations, and service escalations. A common setup is a few months of heavier involvement, then lighter availability. What usually makes this go smoothly is specificity. Define what you will do, how often, and who becomes the long-term owner for each area. The transitioning guide helps you map that handoff.
How do non-competes usually work when selling a medical device company?
Non-competes are designed to stop you from selling the company and immediately building a direct competitor. In medical devices, buyers often define the restriction around a product category and end market, and sometimes by geography if the sales motion is regional. Many deals also include non-solicitation of employees and key accounts. The scope should match what you actually sold and still let you work in unrelated areas. Your attorney should tailor the wording carefully.
What is a holdback or escrow in a medical device acquisition?
A holdback, sometimes held in escrow, is a portion of the purchase price that stays back for a period after closing to cover specific risks. In medtech, it often relates to product liability exposure, warranty claims, inventory quality, or unresolved quality events that could turn into corrections or removals. A holdback is common. The details matter, like what triggers a claim and when unused funds get released. Rejigg’s due diligence and closing guide covers the usual patterns.
What documents should I put in a data room for selling a medical device company?
A practical medtech data room includes clean financials, customer and distributor agreements, insurance, and HR basics. Then add the device-specific layer buyers will ask for: regulatory status by SKU, labeling and UDI control, complaint and CAPA examples, supplier and contract manufacturer quality evidence, a readable design and change summary, and installed-base and service performance. Rejigg includes a built-in secure data room so you can control access by phase instead of emailing sensitive attachments.
How do taxes work when selling a medical device company?
Taxes depend on whether you sell assets or stock, how the company is set up, and how the price gets allocated across items like inventory, equipment, and intellectual property. Device deals can add wrinkles because inventory can be meaningful, and design documentation or software may carry real value. Talk with a deal tax advisor early so you know what you are agreeing to when offers come in. Rejigg’s negotiation guide explains the trade-offs you’ll see.
How should I price and present inventory in a medical device sale?
Buyers look closely at inventory because it can hide risk in medtech. The common issues are expired materials, obsolete revisions, reworked parts with unclear disposition, or finished goods tied to older labeling. A clean approach is to break inventory into raw materials, work-in-process, and finished goods, then flag slow-moving items with your plan. If you can tie finished goods to lot or serial traceability and show quality release status, buyers usually get more comfortable paying for it.
What are typical deal structures for medical device companies (cash, seller financing, etc.)?
You’ll see mixes of cash at close, seller financing, earnouts, and holdbacks. In medtech, the structure often reflects how confident the buyer feels about regulatory posture, quality execution, and manufacturing continuity. When those areas feel fuzzy, buyers push more value into “later” buckets. When the diligence story is tight, structures tend to get cleaner. Rejigg’s deal tracking lets you compare offers on structure, not just headline price.
How do I find buyers for a medical device company without a broker?
You find buyers by running controlled outreach and giving serious buyers enough device-specific proof to lean in. That usually means a clear claims and status summary, regulatory timeline, QMS evidence, design and change digest, installed-base behavior, and a supplier risk map. Rejigg is built for broker-free sales. It brings pre-vetted buyers, digital NDAs, direct messaging, scheduling, and a secure data room. Start with the finding buyers guide to structure outreach.
What’s the best time of year to sell a medical device business?
Timing is mostly about diligence readiness, not the calendar. Many medtech deals slow around major holidays and during heavy conference seasons since quality and regulatory teams get pulled in multiple directions. Buyers still move when the story is organized and document-backed. Start when you can answer claims, regulatory, quality, installed-base, and manufacturing questions without improvising. If you want to plan your timeline, book a call at schedule a consultation.