Editorial Guidelines

How is company information populated?

MedTechIndex company profiles are developed through a combination of independent research, publicly available data, and AI-assisted drafting. Each profile undergoes human editorial review before publication, with a human editor responsible for evaluating the accuracy, relevance, and presentation of published content.

Information is gathered from manufacturer websites, official regulatory databases, company announcements, and other publicly accessible records. Features such as FDA regulatory filings and job postings draw from their respective primary sources whenever available.

AI tools assist with researching, organizing, and summarizing information but do not replace human editorial judgment. Where possible, source references are provided so readers can examine important claims. Information may change over time, and we welcome factual corrections.

How does MedTechIndex verify company information?

MedTechIndex gathers company information from official company websites, regulatory databases, corporate announcements, industry publications, and other credible records.

We prioritize primary sources wherever possible and may cross-reference information from multiple sources to assess reliability. When sources conflict, our editorial team evaluates the available evidence. Information that cannot be sufficiently substantiated may be qualified, withheld, or omitted.

We distinguish independently documented facts from company-reported claims about products, performance, partnerships, or commercial activities. Such claims are not automatically treated as independently verified facts.

All profiles undergo human editorial review before publication. This review is not an independent audit and does not guarantee the accuracy or completeness of every detail.

How frequently is company information updated?

MedTechIndex profiles are reviewed and updated periodically to reflect developments such as regulatory milestones, product launches, funding activity, partnerships, and other material changes.

Update frequency may vary by company, information type, and underlying source. FDA records and active job postings, for example, may be refreshed independently of the broader profile.

As MedTechIndex is currently in beta, we are continuing to evaluate and refine our data collection and update processes to determine an appropriate refresh schedule for different types of information.

We cannot guarantee that every profile reflects the latest developments at all times. Manufacturers and readers are encouraged to report significant changes or corrections.

How can readers report inaccurate information?

MedTechIndex welcomes factual corrections, updated information, and reports of potential inaccuracies from manufacturers, distributors, industry professionals, and other readers.

Corrections may be submitted by email to [email protected]. Please identify the relevant profile, describe the information believed to be inaccurate or outdated, and provide supporting documentation or source references where available.

All requests are subject to editorial review. MedTechIndex may verify submissions against additional sources and may decline changes that cannot be adequately substantiated.

There is no fee to submit a correction or request an update. During beta, we cannot guarantee a specific response or resolution timeframe.

Where does MedTechIndex obtain regulatory information?

MedTechIndex sources U.S. medical device regulatory information primarily from publicly available records maintained by the U.S. Food and Drug Administration (FDA). These may include device classifications, 510(k) clearances, premarket approvals (PMAs), establishment registrations, and other relevant filings.

We identify relevant records using company and applicant names, product names, regulatory identifiers, and, where applicable, predecessor or acquired-company names. Records are reviewed for their connection to the company and its products; a similar name alone is not sufficient to establish a match.

Regulatory information on MedTechIndex summarizes the published records reviewed. It is not a safety assessment, a determination of compliance, or a complete worldwide regulatory or recall history. Some records may be unavailable, may not be attributable to a particular company, or may not yet appear in our database. Missing records or unknown counts do not mean zero events, lack of required authorization, or noncompliance.

FDA clearance, approval, registration, and listing are distinct regulatory processes and should not be interpreted interchangeably. Consult official FDA databases for definitive regulatory information.

For current recall instructions, affected models or lots, and corrective actions, consult the linked FDA records and manufacturer notices.

How should I read the Regulatory Snapshot on a company profile?

The Regulatory Snapshot summarizes documented FDA 510(k) clearances, De Novo grants, PMA approvals and recall events associated with a company’s current commercial products. Counts reflect regulatory records, rather than individual products. PMA totals include original approvals only; supplements are excluded.

Authorization counts reflect distinct regulatory decisions, not the number of individual models, configurations, or units sold. Multiple recall records associated with the same FDA recall event are counted as one event.

Discontinued or divested products and records we cannot confidently link to the current portfolio are excluded from the totals. Documented open recalls may also appear below the snapshot, including events excluded from the count because their connection to the current portfolio remains unresolved. Recall status reflects the date each record was last checked.

A “+” indicates a documented minimum, meaning additional records may exist. A dash (“—”) means we have not established a count; it does not mean zero. Company-specific notes explain relevant qualifications.

A displayed zero means no matching records were identified within the documented search scope as of the review date. It does not establish that no such records or events have ever existed. Counts may change as additional records become available or their connection to the company’s current portfolio is established.

What can I learn from regulatory and recall counts?

Counts summarize documented regulatory activity within the scope described in the Regulatory Snapshot. They are not safety ratings, measures of product quality, or rankings of manufacturers.

More clearances or approvals do not, by themselves, establish that a company’s products are better or more effective. Similarly, fewer recalls do not establish greater safety. Counts can reflect differences in portfolio size, product types, company history, and available records, and do not account for the number of devices sold or used.

Recall counts alone do not convey the seriousness of an event, the number of affected devices, or whether corrective action remains outstanding. Those details should be assessed using the specific recall information and linked FDA records or manufacturer notices.

MedTechIndex’s regulatory coverage is not a complete worldwide history or an independent assessment of safety or compliance. Where relevant, profiles explain product-specific restrictions, uncertainties, and recall details.

Does MedTechIndex include regulatory information from outside the United States?

MedTechIndex is a global medical device intelligence platform, featuring manufacturers from around the world regardless of their geographic location or markets served.

During initial development, we are prioritizing U.S. FDA regulatory information. Data displayed on company profiles therefore primarily reflects U.S. records and should not be interpreted as a complete picture of global regulatory status.

We recognize regulatory jurisdictions including the European Union, United Kingdom, Canada, Australia, and markets throughout Asia. As MedTechIndex evolves, we intend to evaluate additional sources for international regulatory activity and market access.

The absence of U.S. FDA records does not preclude inclusion in MedTechIndex or imply that a manufacturer’s products lack authorization in other markets.

How does MedTechIndex distinguish manufacturers, distributors, suppliers, and developers?

We classify companies by their documented role in the medical device market:

• Manufacturers bring medical devices to market under their own name or brand. They may produce devices themselves or use manufacturing partners.
• Developers work on devices or technologies that may still be in research, clinical development, or preparation for launch. “Manufacturer / Developer” indicates a company with both marketed products and products in development, or overlapping development and manufacturing activities.
• Distributors sell or supply other manufacturers’ finished devices to healthcare providers, resellers, or other buyers.
• Suppliers provide components, materials, equipment, or specialized services used to develop, manufacture, or support medical devices.

These roles can overlap. Labels reflect the activities documented in our research and are editorial descriptions, not formal regulatory designations.

Our beta currently focuses on manufacturers and developers. Dedicated distributor and supplier intelligence is coming soon; verified distribution relationships may already appear within manufacturer profiles.

How are companies selected for inclusion?

MedTechIndex is an independently curated directory of medical device manufacturers and developers across global markets. During beta, companies are selected by our editorial team through industry research, professional networks, and publicly available information. We are not currently accepting open submissions, although we anticipate introducing a submission process as the platform evolves.

General selection criteria include industry relevance; verifiable business identity; an official website or equivalent authoritative presence; documented product development, manufacturing, or commercial activity; and sufficient reliable public information to create a meaningful profile.

FDA clearance or approval, U.S. presence, and any particular revenue or employee threshold are not required. MedTechIndex may decline, suspend, or remove profiles where credible evidence raises substantial concerns about fraud, misrepresentation, or business legitimacy, following editorial consideration of the available evidence.

Inclusion is not contingent upon payment, sponsorship, or an existing commercial relationship. Meeting general eligibility criteria does not guarantee publication.

What types of companies are not eligible for inclusion?

MedTechIndex primarily covers businesses involved in medical device development, manufacturing, and commercialization. Not every healthcare-related company falls within that scope.

Generally outside current coverage are pharmaceutical or biotechnology companies focused exclusively on drugs; healthcare providers that do not develop or manufacture devices; wellness, nutrition, and supplement brands without a meaningful device program; healthcare marketing and consulting firms; and general-purpose technology companies without a medical device offering.

Adjacent businesses, including distributors, contract manufacturers, component suppliers, and developers of drug-device combination products, may become eligible as coverage expands. Eligibility depends on actual products and activities rather than industry labels alone.

Will MedTechIndex include distributors, suppliers, and contract manufacturers?

While MedTechIndex initially focuses on medical device manufacturers and developers, our long-term vision encompasses the broader medical device ecosystem.

We anticipate expanding coverage to distributors, specialized suppliers, contract manufacturers (CMOs), and contract development and manufacturing organizations (CDMOs).

During beta, we are prioritizing manufacturer profiles. Documented relationships with distributors, suppliers, and manufacturing partners may appear within existing profiles when supported by credible sources.

Dedicated profiles for additional company categories are planned for future development, with eligibility criteria and profile structures tailored to their roles.

Are MedTechIndex company profiles free?

Yes. Standard company profiles are published at no cost to featured manufacturers. There is no fee to submit factual corrections or updates.

MedTechIndex may introduce optional paid features, enhanced profiles, or additional services as the platform evolves. Any paid promotional placements, if offered, will be distinguished from independent editorial content.

Payment will not determine editorial inclusion, the accuracy of published information, or favorable editorial treatment. Paid participation will not influence organic editorial rankings.

Can companies change information on their profile?

Featured companies are encouraged to report inaccuracies, outdated information, and omissions by emailing [email protected]. Examples include leadership changes, products, locations, and partnerships.

All submissions are reviewed before publication. MedTechIndex retains final editorial control, including over financial information, regulatory records, and independently sourced data. Companies may provide evidence of errors but cannot directly modify these records.

Claiming a profile does not grant preferential organic placement, higher editorial rankings, or favorable editorial treatment. Editorial decisions remain independent of company participation or commercial relationships.

How does MedTechIndex verify commercial relationships?

MedTechIndex documents distribution agreements, reseller arrangements, manufacturing partnerships, and other commercial relationships using public information from manufacturers, distributors, and other credible sources.

For our Documented Distributors & Resellers feature, we prioritize current product listings, official company disclosures, and other evidence that a company distributes or offers the manufacturer’s products. Historical announcements alone are insufficient evidence of an ongoing relationship without additional corroboration.

Information is reviewed before publication and source references are provided where available. Inclusion does not necessarily indicate a formal contractual relationship, exclusive rights, or independently confirmed authorization from the manufacturer.

Relationships and product availability can change. We encourage reports of outdated or inaccurate information.

How does MedTechIndex source and verify job postings?

MedTechIndex’s Hiring & Expansion Signals feature highlights publicly advertised opportunities at companies featured in our directory.

Listings are sourced from company career pages, applicant tracking systems, and publicly accessible recruitment platforms. We prioritize listings traceable to an identifiable employer or official application page.

Where possible, postings are checked for availability before publication. Expired, inaccessible, or unverifiable listings may be excluded or removed during later reviews. Readers should confirm current availability and position details with the employer.

Hiring activity can provide context about operations and potential growth priorities but is not definitive evidence of expansion, financial performance, or commercial success.

Does inclusion in MedTechIndex constitute an endorsement?

No. Inclusion in MedTechIndex is intended to support independent research and discovery. It is not an endorsement, certification, or recommendation of a company, its products, services, business practices, or regulatory compliance.

Information on the platform should not be treated as a substitute for regulatory review, procurement diligence, clinical evaluation, legal advice, or investment research. Readers should independently verify material information and conduct appropriate due diligence before making commercial or other consequential decisions.

Editorial inclusion and coverage do not imply any affiliation with, sponsorship by, or approval from the companies featured.