Top Regulatory & Quality Control Providers

Rating: 5/5- 25 reviews

HaA Design is a full-service Medical ISO-13485 certified design and product development company, providing an extensive range of services including product management, research, design, engineering and manufacturing. We promote fresh & creative thinking in everything we do. Great product... Read More

www.haapd.com

Regulatory experts can be difficult to find, especially at reasonable rates. Cadence Regulatory offers strategic counsel as well as medical device market application and document review services for the medical device industry. At Cadence Regulatory, Robert Wolfarth uses over 30 years of... Read More

www.cadenceregulatory.com

Natech Plastics is an ISO 13485 and 9001-certified provider of product development, custom injection molding, and contract manufacturing services. We also specialize in design for manufacture and scientific molding services, which ensure streamlined schedules and more stable processing for... Read More

www.natechplastics.com

MethodSense, Inc.'s ISO 13485 Consultants guide medical device companies through the meticulous journey of achieving ISO 13485 certification, underpinning a firm commitment to quality management and regulatory compliance. Leveraging our proprietary LuminLogic Smart Enterprise Suite and deep regulatory knowledge, we provide a comprehensive package that not only simplifies the compliance process but also fosters efficient validation and improved process management, tailored to align with FDA 21 CFR Part 820 compliance. Our expert medical consultants are dedicated to facilitating easier compliance, ensuring that your medical devices meet global quality and safety standards with reduced time-to-market, thereby cementing your reputation for product excellence and reliability. Our goal is to help you achieve easier compliance, more efficient validation, and improved process management.;

Pace Analytical's regulatory and compliance services encompass a robust suite of ISO 13485 consultancy offerings designed to elevate medical device companies to a state of exceptional quality management and regulatory alignment. Our dedicated team of consultants delivers expert knowledge and tailored strategies to streamline the certification process, ensuring adherence to global medical device standards through comprehensive gap analyses, risk assessments, and the development of thoroughly compliant quality systems. Through our in-depth knowledge and industry-leading practices, you can confidently achieve and maintain ISO 13485 certification, paving the way for sustained quality assurance and compliance excellence in a competitive global market.;

JJK Consulting Inc. prides itself on delivering comprehensive ISO 13485 Transition Consulting Services, adeptly maneuvering companies through the intricacies of medical device regulations to achieve seamless certification. Our expert team offers tailored support, from establishing quality management systems compliant with evolving ISO standards to robust post-certification maintenance, ensuring ongoing adherence, and minimizing re-audit risks. Our ISO 13485 transition consulting team can make sure that the QMS for your medical device initiatives complies with the current standards. With JJK, you're not just meeting international compliance benchmarks but enhancing product credibility and opening doors to global market opportunities with our proven, client-centric consulting methodologies.;

Polymer Solutions Incorporated (PSI) offers regulatory compliance consulting that delivers exceptional quality assurance and compliance services, grounded in our comprehensive understanding of stringent quality frameworks and regulatory standards. Leveraging a robust Quality Management System and cutting-edge electronic document management technology, we guarantee data reliability, methodological integrity, and regulatory adherence, essential for FDA submissions and international compliance. With a focus on custom method development, meticulous release testing for production lots, and end-to-end support for failure investigations, PSI empowers you with defensible documentation and results, ensuring your products meet the highest standards of safety and quality.;

Medical Device Academy specializes in demystifying the complexities of ISO 13485 compliance, offering personalized quality and regulatory consulting services that are specifically crafted to assist small medical device companies in navigating FDA regulations. Our tailored approach includes comprehensive support for 510(k) submissions, FDA pre-submissions, and robust quality system implementation, utilizing streamlined methodologies and training that enhance our clients' readiness for regulatory scrutiny. By empowering start-ups with knowledge, detailed guidance, and a focus on urgent needs for timely market entry, we ensure that our clients not only achieve compliance but do so with a strategic advantage uniquely shaped for future industry success.;

Operon Strategist is a premier consultancy firm that focuses on providing end-to-end solutions for regulatory compliance in the medical device industry. As a leader in the healthcare sector, the company specializes in guiding manufacturers and service providers throughout the entire product life... Read More

Lean ISO Experts offers expert consulting services, including quality management system (QMS) implementation specific to the ISO 13485 standard, catering to medical device manufacturers. We provide supportive, comprehensive solutions ranging from documentation creation and QMS implementation to providing specialized in-house quality and inspection personnel, streamlining your path to compliance efficiency by performing internal quality audits, saving valuable resources, and providing impartial assessments. Backed by hands-on training and the leverage of Lean methodologies, we empower manufacturers with robust systems that not only satisfy regulatory requirements but also elevate product quality and operational excellence.;