OUR SERVICES
We are a leading medical device regulatory consulting company, offering expert services to help manufacturers navigate the complex world of medical device regulations. Our core services include CE Marking, ISO 13485, US FDA 510(k), Clinical Evaluation, and more. We assist with various regulatory needs, such as country-specific registrations, authorized representative appointments, external testing, EUDAMED registration and UDI labelling. Our team also provides internal audits, gap analysis, training, mock audits, conformity assessments, document preparation, and audit NC closures. For clients facing specific documentation challenges, we offer customized services to prepare necessary documents, including technical files, risk management reports, clinical evaluation plans (CEP), clinical evaluation reports (CER), and post-market surveillance plans (PMSP). With a focus on ensuring safety, quality, and faster market access, we work closely with clients to develop products that meet regulatory standards. Our medical device regulatory consultants streamline processes, minimize risks, and ensure compliance, helping our clients bring safe and reliable products to market quickly.
- Europe
- India
- USA
- UK
- Others
We provide a wide range of medical device regulatory consulting services to help manufacturers ensure their products meet safety and quality standards. Our expertise covers various types of medical devices across all classes (Class I, IIa, IIb, III). We support devices with services including CE marking, clinical evaluation, ISO 13485 certification, US FDA 510k approval, and more. As trusted medical device regulatory consultants, we guide manufacturers through the design, development, validation, and approval process, ensuring their products are safe, innovative, and ready for the market.
Services We Provide Under CE Certification Consultants
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We provide a full range of medical device regulatory consulting services, covering everything from low-risk to high-risk devices. Our expertise includes CE marking, clinical evaluation, ISO 13485, US FDA 510k, CDSCO and more, helping manufacturers navigate the entire lifecycle of their products. We assist with everything from product design and development to regulatory approval, post-market surveillance, and ongoing compliance. As trusted medical device regulatory consultants, we're here to guide you through each step of the process with expertise and support.
Services We Provide For India
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We provide expert medical device regulatory consulting services to help manufacturers navigate the complex process of CE marking, clinical evaluation, ISO 13485 certification, US FDA 510k approval, and more. As trusted medical device regulatory consultants, we support you at every step, from certification to ensuring that your devices meet all safety and regulatory standards. Our services are designed to help you bring your products to market with confidence, ensuring full compliance with necessary regulations for success.
Services We Provide For USA
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We are a leading medical device regulatory consulting firm offering a range of services to help manufacturers meet regulatory standards for their products. Our expertise includes CE marking, clinical evaluations, ISO 13485 certifications, US FDA 510(k) approvals, and more. We assist manufacturers throughout the entire process, from product development to post-market surveillance, ensuring their devices meet safety and performance standards. As trusted medical device regulatory consultants, we help clients navigate complex regulations and ensure their products are compliant and ready for the market.
Services We Provide For UK
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We are a leading medical device regulatory consulting service provider, offering expert guidance in areas like CE marking, clinical evaluation, ISO 13485 certification, US FDA 510k, and more. Our services cover all device classes (I, II, and III), ensuring compliance with global regulations. Whether you're dealing with high-risk implants or low-risk disposables, we support you through the entire lifecycle—from design and development to post-market surveillance—ensuring that your products meet the necessary safety, efficacy, and performance standards. Our expertise gives you confidence that your medical devices are fully compliant with relevant regulations, allowing you to bring them to market with peace of mind.
Services We Provide
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