ISO 13485 Providers in
United States
Find verified ISO 13485 Medical Devices Quality Management consultants, certification bodies, and training providers in United States. Compare profiles, read reviews, and get free quotes — no obligation.
If you are looking for the fastest, top notch ISO certification consultation at the lowest cost. Compliancehelp is an Australian consultancy firm specialising in ISO 9001, ISO 14001, AS/NZS 4801, ISO 31000, ISO 27001, AS 5377, ISO 17025, ISO 45001, ISO 55001 and ISO 50001. Since 2000, Compliancehelp has helped companies like yours prepare for and achieve certification in as little as 90 days. We now have an office in North America since 2012
QMS Certification is an accredited third party certification body, it is currently present in more than 30 countries and focuses on the certification of management systems. QMS Certification is managed by the US office and has consistently grown in market recognition by technical level, customer satisfaction and competitive pricing.
Concentric Global is a consulting services firm that leverages the expertise of industry leaders and subject matter experts to make the best companies in the world even better through consulting, training, auditing, and digital tools. We provide support to businesses of all shapes, sizes and sectors who are in major growth phases. The 12-Tools Methodology and the concept of a ?concentric management systems? was created by our Founder James R Thompson in 2003. At the core of our services and digital products is the idea that compliance and business optimization can be achieved through ?having a common center? (the definition of the word concentric).? Primary sectors served are automotive, aerospace, medical device, information systems and education. We provide systemic guidance and implementation services focused on top-line revenue generation and operational improvements resulting in sustainable growth and value to the customer.
At RPM Consulting Inc., we specialize in helping businesses achieve and maintain?ISO 9001 certification?training and consulting services. With a strong focus on?Quality Management Systems, our goal is to empower your organization to reach its highest potential in efficiency, compliance, and customer satisfaction. Our unique, integrated methodology ensures continuous improvement in your business management systems, driving significant cost savings and operational excellence.
Liberty Management Group Ltd, (LMG)?was established in 2009.? We are a leading international quality management system consulting group providing various services such as?ISO consultation, GMP?and?CE marking.In addition to our US offices in?New York?(Serving New York, Connecticut, Boston, New Jersey, Philadelphia, and Washington DC) and?Chicago?(Serving greater Chicago areas and suburbs), we also have associates and offices around the globe.Liberty Management Group Ltd, (LMG)? experienced consultants can do a GAP analysis and give you an estimate of the cost and the time frame of the process.Our fees are one of the lowest in the industry.? We will quote you a fixed fee for the entire process including certification in the beginning so that you can do your budgeting without any surprises.Our services do not finish once the system is implemented, and you are certified.? We offer ongoing support in keeping your quality management system up to date and performing internal and surveillance audits.Liberty Management Group Ltd, (LMG) believes in ?continual improvement? and that there is room for everyone to grow. We believe in the inherent strength and potential of our customers and their ability to achieve full potential by improving their bottom line.
Headquartered in Southern California with global capabilities, 4K Quality Associates LLC is equipped to meet the quality consulting needs of any organization. Our diverse client base ranges from small automotive parts distributors to leading aerospace manufacturing facilities.At 4K Quality Associates, we possess the resources, flexibility, and expertise to continually enhance your quality management system. Our reputation has grown through building strong relationships with both past and present clients and colleagues.Founded by a team of quality experts with a variety of specialties and a shared vision, 4K Quality Associates LLC provides organizations with the tools needed to continually improve their quality management systems and meet both customer and regulatory requirements.4K Quality Associates LLC is dedicated to helping organizations achieve excellence in quality management.
For over three decades, since 1985, Omnex has been a thought leader, applying thought provoking leadership globally in the field of Business & Process Management Systems for a wide variety of industries.We have been helping our clients raise their performance levels using our methodologies, and have had the successful partnerships with companies from a wide spectrum including Automotive, Aerospace, Electric- Autonomous vehicles, Medical devices, Semiconductor/high-tech and General Manufacturing.We bring in effective deployment of cutting-edge solutions and methodologies, formulating a Quality Centre of Excellence Strategy to improve overall efficiency of our customers by training/ competency development, implementation / mentoring support, and implementing integrated software solutions that lead our clients to a Digital Transformation of their work flows.As a leading international consulting and training organization with offices in all of the major markets around the globe, we bring together world-class talent-innovators and leaders in their fields, with local expertise & deliver high-impact solutions in today's dynamic international business environment. Be it implementation of Integrated Management Processes, People Capability Improvement, Operational Strategic improvement, Supply chain improvement or Systems Compliance, we welcome you to be a part of the revolutionary Omnex Advantage.Omnex combines extensive knowledge in business excellence practices with an impressive depth and breadth of industry experience to build and strengthen client capabilities. With its own Integrated Business Management System (BMS certified to ISO 9001, ISO 14001, ISO 45001, and ISO 27001), Omnex is committed to comprehensive and sustainable enterprise excellence.
Soma Associates is a?management system that does not help drive business performance is not effective. In measuring management systems? performance, what matters most is impact on your bottom line. Soma Associates leads transformation efforts. We create management systems based on executives? core knowledge requirements. At the same time, our proprietary methodology streamlines processes to cut waste and improve efficiency and results. We enable total management systems integration, unleashing a better business management system based on the core business mission and success metrics of the company.
CertPro is a global company of auditors and consultants who deliver turnkey projects for all your compliance auditing, consulting, and certification needs. Projects are effectively delivered using industry best practices, keeping in mind your required timelines and set budgets, utilizing all available resources efficiently.We are updated with the constant technological developments in the compliance field, with a team of tech-forward auditors and consultants who not only understand your information systems deeply, but who also excel at auditing compliance automation tools.We always find new and innovative methods to expedite projects, moving away from traditional mindsets around compliance auditing.Companies are developing global business structures that require specific information security requirements to grab international markets.CertPro provides uncomplicated auditing and consulting services to achieve industry-specific credibility. Massive data models are produced and utilized regularly, which is the lifeblood of today?s business ecosystems. Digitalizing operational models increases the risk of digital vulnerabilities ? making cybersecurity and data privacy a prime concern for organizations.Our solutions-centric mindset aims to cater to this niche ? ensuring that information security, and compliance in general, is more accessible, easy to understand and affordable.
Since 2012, Rook has been dedicated to helping medical device companies develop and maintain effective and efficient quality systems, and to providing them with the right resources and expert insight. Our mission is to enable our clients to implement compliant Quality Management Systems (QMS) to ensure that they can efficiently produce effective and reliable medical devices. We build these QMSs so that our clients can get their devices to market faster than standard methods, and once on the market, manage these systems to continue producing quality devices.The RookQS team leverages its extensive experience and expertise in quality and regulatory strategies for emerging and established medical device companies to help our clients get their devices to market significantly faster than standard methods.Our consultants provide clients with the necessary tools to comply with regulations in both domestic and international markets, with specialists in FDA regulations, MDSAP audits, ISO 13485:2016 compliance, and MDR conformity. Our diverse team works with a wide range of devices (including class I-III devices, SaMD, and IVDs).RookQS? team of experienced, certified Quality Engineers features 13 certified quality auditors (CQAs) for a variety of regulations, including FDA 21 CFR 820, ISO 13485:2016, MDSAP, and CE Mark under MDR.
Verified Providers
Consultants, certification bodies, and training providers based in or serving United States
Free Quotes
Submit one request and receive quotes from multiple ISO 13485 specialists in United States within 24 hours
All Services Covered
Gap analysis, implementation, internal audit, training, and certification body services all available
ISO 13485 providers in other locations
FAQ
Common questions
About iso 13485 providers in united states.
CertBetter lists verified ISO 13485 Medical Devices Quality Management providers based in or serving United States. Filter by service type (consultant, certification body, training), compare profiles and verified reviews, and submit a single free quote request to hear from multiple specialists simultaneously.
Not necessarily. Many ISO 13485 Medical Devices Quality Management consultants work remotely with clients worldwide and can deliver gap analysis, documentation, and training entirely online. However, a locally based consultant in United States may have an advantage for on-site work, regulatory familiarity, and surveillance audit support.
Total ISO 13485 Medical Devices Quality Management certification costs in United States typically range from $5,000 for a micro business to $60,000+ for a complex medium-sized organisation. This covers consultant fees (gap analysis, implementation, documentation, training) plus certification body audit fees (Stage 1 and Stage 2). Getting multiple quotes through CertBetter is the fastest way to benchmark pricing.
Most United States businesses complete first-time ISO 13485 Medical Devices Quality Management certification within 4–12 months. Organisations with existing documented processes and a dedicated internal lead move significantly faster — sometimes within 3 months. A gap analysis at the start is the best way to set a realistic and accurate timeline.
A ISO 13485 Medical Devices Quality Management consultant helps you prepare — conducting gap analysis, building documentation, training staff, and getting audit-ready. A certification body (CB) is an accredited organisation that independently audits your management system and issues the certificate. They are separate roles, and you typically work with both. CertBetter lists both types in United States.
Technically yes, but it is significantly harder and slower without expert guidance — especially for first-time certification. Most United States businesses that attempt self-certification take longer, face more audit non-conformances, and end up spending more overall. A consultant typically pays for themselves in time savings and reduced re-audit risk.