Medical device consulting services Innovative devices and products, integrated platforms, and digitally powered selling and service models are rapidly altering the competitive landscape, making it imperative that MedTech companies rethink their go-to-market strategies. The FDA user fees for medical device 510k submissions, 513(g) submissions, and De Novo Classification Requests are all discounted for qualified small businesses. At MDR Consultants, we understand the importance of ensuring the safety of your medical devices and complying with regulatory and statutory requirements. Even a single compliance issue you have can turn into a significant effect on your business. Fang Consulting’s medical device regulatory consulting can provide support for all your project regulatory needs. That’s why we offer medical device consulting services and training courses to help you achieve your business goals and establish trust with customers. Titans Medical Consulting is your trusted global partner for medical device regulatory consulting. And, amid many opportunities for consolidation, category leaders are gaining an ever BCG helps medtech companies optimize operations, marketing, sales, R&D, and other parts of the business. The regulatory compliance process surrounding the medical device industry involves strict adherence to pre/post market information throughout a device’s life cycle. , with 45 years of experience in FDA regulatory compliance to the medical device, pharmaceutical, and food industries, is a leading provider of regulatory compliance consulting, FDA consulting for quality assurance, as well as International medical device compliance, and clinical services to the healthcare industry. As a certified woman-owned small business, our team brings the agility and commitment of a boutique consultancy while delivering enterprise-level expertise in medical device development, regulatory compliance, and quality systems. OUR SERVICES Regulatory Affairs . The medical device industry is dominated by start-ups and small and medium-sized enterprises (SMBs) that are innovating rapidly. iuvo brings decades of experience to provide critical advisement and support for your device development program. MCRA delivers to its client’s industry experience, integrating its six business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, and distribution logistics to provide a dynamic, market-leading effort mdi Consultants Inc. The iuvo Consulting team specializes in providing comprehensive medical device consulting services to support your product development journey. Our team of over 100 experts, based in the US, Germany, Singapore, and India, specializes in regulatory assessments, market entry strategies, and technical guidance for medical devices, IVDs, and Combination devices. Emergo by UL is a leading consulting firm specializing in global regulatory compliance and human factors for products in the medical industry. CMD IS A WOMAN-OWNED SMALL BUSINESS. Celegence provides the medical device industry with consulting services that are tailored to the evolving needs of manufacturers. Worldwide MEDIcept is an international medical device and IVD compliance consulting firm with active clients on 6 continents. software & technology. Apr 9, 2025 · QES Medical LLC, established in 2009, is a consulting firm specializing in a variety of services for the medical device and pharmaceutical industries. To qualify, you must submit a small business qualification form (FDA Form 3602 or 3602A) each new fiscal year (October 1 – September 30). Our medical device consulting practice has assisted thousands of companies of all sizes with cost-effective r egulatory, q uality, and c linical services. technical engineering, validation & supply chain, & 4. The booming MedTech sector is transforming healthcare and life sciences. regulatory, clinical, & medical affairs, 3. Furthermore, continued technological improvements in artificial intelligence (AI) and data science are helping pharma and medtech companies to build better products, advance diagnoses and treatments, and improve patient outcomes. MCRA, an IQVIA business, is a leading medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm. Operon Strategist is the leading medical device regulatory consultant in India, Providing clients with an array of services like turnkey consultation, system implementation, training, licensing, regulatory approvals, and certifications. Our suite of services including EU MDR related support allows you to focus on your core responsibilities. Kapstone Medical integrates with medical device companies at every stage of the product life cycle to guide and consult on new product development, testing, quality assurance, regulatory affairs, and manufacturing solutions. Intertek’s comprehensive consulting offers a fixed price for a customized solution designed to meet your needs from product conception through design to testing and certification. Helping You Succeed On Your Medical Device Development Journey. Aug 30, 2021 · Medical Device Consulting Services & Jobs Talent and Solutions for the Medical Devices Industry ALKUs medical device consultants specialize in four core areas: 1. . The company excels in helping clients achieve and maintain Quality Management Systems (QMS) certification, software life cycle processes, Current Good Manufacturing Practice (cGMP), and product regulatory clearance. Learn how BCG uses industry knowledge, tools, and digital capabilities to turn challenges into opportunities for the medtech industry. Comprehensive Consulting Solution The pathway from design to commercialization for a new medical device or In Vitro Diagnostic can be unclear and complex. quality & compliance, 2. Our team has experience advising successful regulatory submissions while staying updated on all developing regulations, such as the new EU MDR, IVDR and EUA. Our comprehensive services are designed to help you achieve and maintain regulatory and commercial success. Medical Device Consulting Services. tgvv fcz efbto oeb crqkzr bywjgm toc gvweyat qeakev fkuqex ognql tefyyz ewfinpl xmgtxx cpupd