Zomedica Achieves ISO 13485 Certification, Underscoring Strengthened Quality Infrastructure and Commercial Potential
Zomedica (OTCQB: ZOMDF) announced it has earned ISO 13485:2016 certification for its manufacturing and distribution operations in Plymouth, Minnesota and Roswell, Georgia on November 6, 2025. The certification followed an independent audit validating conformity with medical device quality-management requirements across design, production, risk management, servicing, and regulatory compliance.
Management said the certification strengthens quality infrastructure, supports global market readiness and regulatory filings, enhances customer and partner confidence, promotes operational efficiency, and positions Zomedica to scale diagnostics and therapeutics — including potential products for the human health market.
Zomedica (OTCQB: ZOMDF) ha annunciato di aver ottenuto la certificazione ISO 13485:2016 per le proprie attività di produzione e distribuzione a Plymouth, Minnesota e Roswell, Georgia in data 6 novembre 2025. La certificazione è il risultato di un audit indipendente che ha convalidato la conformità ai requisiti di sistema di gestione della qualità per dispositivi medici, che riguardano progettazione, produzione, gestione del rischio, assistenza e conformità normativa.
La direzione ha dichiarato che la certificazione rafforza l'infrastruttura della qualità, sostiene la preparazione ai mercati globali e le pratiche regolatorie, aumenta la fiducia di clienti e partner, promuove l'efficienza operativa e posiziona Zomedica per scalare diagnostica e terapie, includendo eventuali prodotti per il mercato della salute umana.
Zomedica (OTCQB: ZOMDF) anunció que ha obtenido la certificación ISO 13485:2016 para sus operaciones de fabricación y distribución en Plymouth, Minnesota y Roswell, Georgia el 6 de noviembre de 2025. La certificación siguió a una auditoría independiente que validó la conformidad con los requisitos de gestión de la calidad de dispositivos médicos en diseño, producción, gestión de riesgos, servicios y cumplimiento regulatorio.
La dirección dijo que la certificación fortalece la infraestructura de calidad, respalda la preparación para mercados globales y presentaciones regulatorias, aumenta la confianza de clientes y socios, fomenta la eficiencia operativa y posiciona a Zomedica para escalar diagnósticos y terapias, incluyendo posibles productos para el mercado de la salud humana.
조메디카(Zomedica) (OTCQB: ZOMDF)은 제조 및 유통 운영에 대해 ISO 13485:2016 자격을 2025년 11월 6일 미네소타주 플리머스와 조지아주 로스웰에서 획득했다고 발표했습니다. 이 인증은 설계, 생산, 리스크 관리, 서비스 및 규제 준수를 포함한 의료기기 품질 관리 요구사항의 적합성을 독립적인 감사로 확인했습니다.
경영진은 이 인증이 품질 인프라를 강화하고, 글로벌 시장 준비 및 규제 제출을 지원하며, 고객과 파트너의 신뢰를 높이고, 운영 효율성을 촉진하며, 인간 건강 시장에 대한 잠재 제품을 포함한 진단 및 치료제를 확장하기 위한 위치를 마련한다고 말했습니다.
Zomedica (OTCQB: ZOMDF) a annoncé avoir obtenu la certification ISO 13485:2016 pour ses activités de fabrication et de distribution à Plymouth, Minnesota et Roswell, Georgia le 6 novembre 2025. La certification résulte d'un audit indépendant ayant validé la conformité aux exigences du système de gestion de la qualité des dispositifs médicaux, couvrant la conception, la production, la gestion des risques, le service et la conformité réglementaire.
La direction a déclaré que cette certification renforce l'infrastructure qualité, soutient la préparation des marchés mondiaux et les dépôts réglementaires, améliore la confiance des clients et des partenaires, favorise l'efficacité opérationnelle et positionne Zomedica pour accroître son offre de diagnostics et de thérapies — y compris des produits potentiels pour le marché de la santé humaine.
Zomedica (OTCQB: ZOMDF) gab bekannt, dass sie am ISO 13485:2016-Zertifikat für ihre Fertigungs- und Vertriebsaktivitäten in Plymouth, Minnesota und Roswell, Georgia am 6. November 2025 erhalten hat. Die Zertifizierung folgte einer unabhängigen Prüfung, die die Übereinstimmung mit den Anforderungen des Qualitätsmanagementsystems für medizinische Geräte in Design, Produktion, Risikomanagement, Wartung und regulatorischer Compliance bestätigte.
Die Geschäftsführung sagte, dass die Zertifizierung die Qualitätsinfrastruktur stärkt, die globale Marktreife und regulatorische Einreichungen unterstützt, das Vertrauen von Kunden und Partnern erhöht, die operative Effizienz fördert und Zomedica positioniert, Diagnostik und Therapeutika auszuweiten — einschließlich potenzieller Produkte für den Markt der menschlichen Gesundheit.
Zomedica (OTCQB: ZOMDF) أعلنت أنها حصلت على شهادة ISO 13485:2016 لعمليات التصنيع والتوزيع الخاصة بها في بليموث، مينيسوتا وروزويل، جورجيا في 6 نوفمبر 2025. جاءت الشهادة بعد مراجعة مستقلة أكدت التوافق مع متطلبات إدارة جودة الأجهزة الطبية عبر التصميم، الإنتاج، إدارة المخاطر، الخدمة والامتثال التنظيمي.
قالت الإدارة إن الشهادة تقوّي بنية الجودة، وتدعم جاهزية الأسواق العالمية والتقديمات التنظيمية، تعزز ثقة العملاء والشركاء، وتُعزّز الكفاءة التشغيلية، وتضع Zomedica في موقع يسمح بتوسيع قدراتها في التشخيص والعلاج — بما في ذلك منتجات محتملة لسوق الصحة البشرية.
- ISO 13485:2016 certification achieved for Plymouth and Roswell sites
- Supports regulatory filings and international market deployment
- Enhances customer, distributor and partner confidence via third-party validation
- Promotes process discipline and cost control through data-driven workflows
- Positions company to scale diagnostics and pursue human health devices
- None.
Certification enhances global market readiness, reinforces quality systems, and supports Zomedica's long-term growth strategy
ANN ARBOR, MI / ACCESS Newswire / November 6, 2025 / Zomedica Corp. (OTCQB:ZOMDF) ("Zomedica" or the "Company"), an animal health company offering innovative point-of-care diagnostic and therapeutic device products for equine and companion animals, today announced that it has earned ISO 13485:2016 certification for its manufacturing and distribution operations in Plymouth, Minnesota and Roswell, Georgia. This milestone further cements Zomedica's commitment to quality, compliance, and global market readiness.
Certification Highlights & Operational Impact
ISO 13485 is an internationally recognized standard for quality management systems tailored to the medical device industry. Its rigorous requirements encompass design, development, production, servicing, risk management, and regulatory compliance over a device's lifecycle. The certification was awarded following an independent audit that validated Zomedica's conformity with these stringent criteria.
"Achieving ISO 13485 certification represents a pivotal milestone for Zomedica, reflecting the quality infrastructure that underpins our growth strategy," said Tony Blair, Executive Vice President and Chief Operating Officer of Zomedica. "This accomplishment not only reinforces our commitment to delivering safe and effective solutions for veterinarians and their patients, but also enhances our ability to expand globally, accelerate market adoption, produce products for the human health market and create long-term value for our shareholders."
Market Insights: Why ISO 13485 Matters to the Business
Securing ISO 13485 certification is not merely symbolic - it delivers concrete strategic advantages that support revenue growth, operational resilience, and competitive positioning. Among the key industry-validated benefits:
Enhanced Access to International Markets & Regulatory Harmonization
ISO 13485 is widely recognized as a global benchmark. Certification can simplify compliance with medical device regulatory regimes in multiple jurisdictions, accelerating product registration and market entry.Stronger Customer Confidence, Credibility & Commercial Appeal
Third-party certification serves as an objectively verifiable endorsement of quality and risk control, increasing trust among customers, distributors, and partners.Operational Efficiency, Process Discipline & Cost Control
ISO 13485 promotes a process-driven, data-centric approach that streamlines workflows, minimizes waste, and reduces variability, contributing to improved margins.Foundation for Innovation and Broader Product Expansion
Certification supports the development of complex new device platforms, including those intended for the human health market, and positions Zomedica for scalable, compliant innovation.
Taken together, these factors suggest that ISO 13485 certification is more than a compliance checkbox-it is a strategic foundation that can contribute to margin expansion, accelerated market penetration, stronger partner relationships, and reduced downside risk.
Strategic Outlook
By achieving ISO 13485 across its Plymouth and Roswell sites, Zomedica reinforces its infrastructure to support both current operations and future growth initiatives, including supply chain expansion and international market deployment. The certification will support regulatory filings, partner due diligence, and customer assurance as Zomedica continues to scale its diagnostics and therapeutic portfolio globally.
About Zomedica
Zomedica is a leading equine and companion animal healthcare company dedicated to improving animal health by providing veterinarians with innovative therapeutic and diagnostic solutions. Our gold standard PulseVet® shock wave system, which accelerates healing in musculoskeletal conditions, has transformed veterinary therapeutics. Our suite of products also includes the Assisi® line of therapeutic devices, the TRUFORMA® diagnostic platform, the TRUVIEW® digital cytology system, the VetGuardian® Zero Touch™ monitoring system, and Vetigel® hemostatic gel, a revolutionary hemostatic agent that rapidly stops bleeding, each designed to empower veterinarians to deliver top-tier care. In the aggregate, their total addressable market in the U.S. exceeds
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Cautionary Note Regarding Forward-Looking Statements
Except for statements of historical fact, this news release contains certain "forward-looking information" or "forward-looking statements" (collectively, "forward-looking information") within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as "plan", "expect", "project", "intend", "believe", "anticipate", "estimate" and other similar words, or statements that certain events or conditions "may" or "will" occur and include statements relating to our expectations regarding future results. Although we believe that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. We cannot guarantee future results, performance, or achievements. Consequently, there is no representation that the actual results achieved will be the same, in whole or in part, as those set out in the forward-looking information.
Forward-looking information is based on the opinions and estimates of management at the date the statements are made, including assumptions with respect to economic growth, demand for the Company's products, the Company's ability to produce and sell its products, sufficiency of our budgeted capital and operating expenditures, the satisfaction by our strategic partners of their obligations under our commercial agreements and our ability to realize upon our business plans and cost control efforts.
Our forward-looking information is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking information. Some of the risks and other factors that could cause the results to differ materially from those expressed in the forward-looking information include, but are not limited to: the outcome of clinical studies, the application of generally accepted accounting principles, which are highly complex and involve many subjective assumptions, estimates, and judgments, uncertainty as to whether our strategies and business plans will yield the expected benefits; uncertainty as to the timing and results of development work and verification and validation studies; uncertainty as to the timing and results of commercialization efforts, including international efforts, as well as the cost of commercialization efforts, including the cost to develop an internal sales force and manage our growth; uncertainty as to our ability to realize the anticipated growth opportunities from our acquisitions; uncertainty as to our ability to supply products in response to customer demand; supply chain risks associated with tariff changes; uncertainty as to the likelihood and timing of any required regulatory approvals, and the availability and cost of capital; the ability to identify and develop and achieve commercial success for new products and technologies; veterinary acceptance of our products and purchase of consumables following adoption of our capital equipment; competition from related products; the level of expenditures necessary to maintain and improve the quality of products and services; changes in technology and changes in laws and regulations; our ability to secure and maintain strategic relationships; performance by our strategic partners of their obligations under our commercial agreements, including product manufacturing obligations; risks pertaining to permits and licensing, intellectual property infringement risks, risks relating to any required clinical trials and regulatory approvals, risks relating to the safety and efficacy of our products, the use of our products, intellectual property protection, and the other risk factors disclosed in our filings with the SEC and under our profile on SEDAR+ at www.sedarplus.com. Readers are cautioned that this list of risk factors should not be construed as exhaustive.
The forward-looking information contained in this news release is expressly qualified by this cautionary statement. We undertake no duty to update any of the forward-looking information to conform such information to actual results or to changes in our expectations except as otherwise required by applicable securities legislation. Readers are cautioned not to place undue reliance on forward-looking information.
Investor Relations Contact:
Zomedica Investor Relations
Investors@zomedica.com
1-734-369-2555
SOURCE: Zomedica Corp.
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