Elevating Manufacturing Efficiency. Precision. Innovation. Reliability.
At Marubeni Citizen-Cincom (MCC), we specialize in providing advanced precision machining solutions for business-to-business clients across industries, leveraging decades of expertise since our founding in 1984. As a collaboration between Marubeni Corporation and Citizen Machinery Co., two of...
Engineered for Excellence. Quality Without Compromise.
About Fort Wayne Metals A leading manufacturer of precision materials used in life-improving medical devices, Fort Wayne Metals is dedicated to making Northeast Indiana and the world a better place. As committed as we are to supporting our customers’ medical technologies, our more than 1,700...
The Global Regulatory Experts Medical Device Compliance Leaders
Health Canada Compliance: Health Canada Compliance for Medical Devices and Health Care Products
Marketing Medical Devices in Canada, the manufacturers, private labelers, importers, and distributors of Medical Devices are required to meet all requirements of the Canadian Federal Regulatory Authority, and its agency...
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Designing the Future of MedTech From Concept to Commercialization
HaA Product Development offers a comprehensive suite of regulatory compliance consultation services, ensuring that products not only meet but exceed the stringent standards set by medical industry regulations including FDA QSR 21 CFR 820 and ISO 13485:2016. Leveraging our deep expertise and tailored methodologies, HaA provides robust support to navigate the complexities of regulatory pathways, enhancing the speed and efficiency of bringing medical devices to market while ensuring full compliance and operational excellence.
Future-Ready Engineering Solutions. Precision. Innovation. Delivered.
Risk Management & Biocompatibility Services: SARACA provides specialized Risk Management and Biocompatibility documentation consulting services for Medical Devices and In Vitro Diagnostics (IVDs) across the entire product lifecycle. Our services align with ISO 14971, ISO 24971, ISO 10993 series, EU MDR (2017/745), EU IVDR (2017/746), and US...
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Fund Better Where Medtech Teams Come to Win.
Quality Systems and Documentation: We provide Quality Systems and Documentation services to ensure your medtech team meets regulatory requirements while maintaining a high standard of operational excellence. Our expertise helps you establish, refine, or scale your quality systems to support compliance with design controls, risk...
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Regulatory, Quality & Clinical Consulting: Strategic Regulatory Consulting & Submissions
PMA, 510(k), NDA, IND, IDE / HDE Submissions, Amendments, Reporting & Supplements
Laser Product Radiation Reports
Establishment Registrations
Device Listings
Experienced U.S. Agent
Negotiations with Government Agencies
International Dossiers, CE...
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TÜV SÜD delivers regulatory compliance consulting with incomparable auditing and system certification services, rooted in deep regulatory knowledge and delivered by highly experienced auditors, ensuring efficiency and compliance on a global scale. Our comprehensive service portfolio spans ISO 9001, ISO 14001, ISO 22301, IATF 16949, ISO/IEC 27001, and more, addressing quality, environmental, information security, and energy management systems. We empower your organization to achieve operational excellence, faster market access, and enhanced profitability by assisting you in becoming more consistent, efficient, and compliant in your business practices.
Integrating Science and Technology
Lyophilization Technology, Inc. specializes in comprehensive consulting services that streamline and enhance the lyophilization process for pharmaceutical and medical products. Our experts offer tailored advice across a broad spectrum, including equipment specification, process requirements, regulatory submission support, and compliance auditing. Leveraging advanced methodologies and in-depth expertise, we facilitate technology transfer, troubleshoot product and process issues, and empower your team through bespoke training, ultimately enhancing your product's readiness and driving success in the market.
Auditing, Testing & Inspection Services
TÜV SÜD America Inc. offers regulatory compliance consulting, providing a suite of medical device testing and certification services, boasting a global team of over 750 experts, including engineers and medical doctors, to deliver comprehensive assessments covering your product's entire lifecycle. We take pride in our in-depth knowledge of the medical device and IVD market, ensuring your testing proceeds smoothly while keeping you abreast of new regulatory requirements to expedite your product's market entry. Our services range from biocompatibility testing and electrical safety testing in accordance with IEC 60601 to EMC testing, functional safety, and MRI safety testing, all designed to ensure the utmost quality, safety, and compliance with global standards. We ensure that medical devices meet rigorous regulatory requirements, accelerating their journey from concept to market readiness.
