Medical Device & IVD Regulatory Consulting Services

Our medical device services encompass a comprehensive range of products, including reusable medical devices, sophisticated medical equipment, disposable devices, advanced implants, drug-device combination products, and home healthcare devices. These services cater to all classes of medical devices, covering Class I, Class IIa, Class IIb, and Class III, ensuring compliance with stringent regulatory standards and safety requirements. We support a diverse spectrum of indications, ranging from diagnostics and treatment devices to therapeutic equipment and surgical tools, addressing the unique needs of manufacturers across various healthcare sectors. Our expertise extends to the design, development, validation, and regulatory approval processes, offering tailored solutions for devices intended for hospital use, clinical settings, or personal home care. By focusing on quality assurance and regulatory compliance, we aim to empower medical device manufacturers to bring safe, innovative, and effective products to market with confidence and efficiency.

Services We Provide For Europe

• CE Certification For Medical Devices

• Medical Device Risk Management

• CE Marking For In-Vitro Diagnostic Device

• Medical Device Clinical Evaluation

• Medical Device Post Market Surveillance

• CE Marking For Medical Device Software

• CE Marking For PPE

• MDR Gap Analysis

• EU Representative Services For Medical Device

• Unique Device Identification Medical Devices

• European Database on Medical Devices

• Medical Device Liability Insurance

• Medical Device Quality Management System

• Benefit-Risk Analysis of Medical Device

• Biological Evaluation of Medical Devices

We offer a comprehensive suite of medical device services that encompass a wide array of products, including reusable medical devices, equipment, disposables, implants, drug-device combination products, and home healthcare devices. Our expertise covers devices across all classifications, from low-risk to high-risk categories, ensuring that we meet the regulatory requirements and safety standards for each. We cater to a diverse range of medical indications, addressing the unique needs of patients and healthcare professionals alike. Our services are designed to support manufacturers throughout the entire lifecycle of their products, from initial design and development to regulatory approval, post-market surveillance, and ongoing compliance management. Whether you're dealing with complex implantable devices, everyday medical disposables, or innovative drug-device combinations, we provide the necessary guidance to ensure your products meet the highest standards of safety, efficacy, and regulatory compliance. Additionally, our expertise extends to home healthcare devices, offering tailored solutions for this rapidly growing sector, ensuring that these products are safe for use in home settings while complying with all relevant regulatory frameworks.

Services We Provide For India

• Medical Device Classification

• Test License for Medical Devices

• Medical Device Manufacturing License

• Medical Device Import License

• FDA Post Approval Changes

• Free Sales Certificate for Medical Device

• Plant Layout Submission CDSCO

• MDR Technical File

• Clinical Trials for Medical Devices

Our medical device services cover a wide array of products, including reusable medical devices, medical equipment, disposables, implants, drug-device combination products, and home healthcare devices. We cater to all device classes, from Class I to Class III, addressing a diverse range of indications across various healthcare sectors. Whether it's high-risk implantable devices, everyday consumables, or innovative drug-device combination products, we provide comprehensive support throughout the product lifecycle. Our expertise ensures that each device meets rigorous regulatory standards and safety requirements, enabling manufacturers to bring their products to market with confidence. Additionally, we offer tailored solutions to support the development, certification, and compliance of these devices, ensuring they are safe, effective, and fully compliant with the relevant regulatory frameworks. From product design to post-market surveillance, our services encompass all aspects of medical device management, helping clients navigate the complexities of regulations and achieve successful market entry.

Services We Provide For USA

• US FDA Consultant

• FDA Food Facility Registration

• FDA Drug Establishment Registration

• FDA Cosmetic Registration

• Registration and Listing of Medical Device

• NIOSH Certification

• US FDA Agent

• USFDA Drug Master Files

• US FDA Label

We offer a comprehensive suite of services for medical devices, covering a wide array of products such as reusable medical devices, equipment, disposables, implants, drug-device combination products, and home healthcare devices. Our expertise spans all device classes, from low-risk Class I devices to high-risk Class III devices, ensuring that we meet the regulatory and safety standards for each product type. We provide support for medical devices across various therapeutic areas and medical specialties, including diagnostics, surgical tools, orthopedic implants, respiratory aids, wound care products, and more. Whether it is ensuring compliance with international regulations like CE marking, US FDA 510(k), ISO certifications, or assisting with clinical trials, risk assessments, and post-market surveillance, we guide our clients throughout the product lifecycle. We help manufacturers address specific requirements for different types of devices, ensuring safety, performance, and effective functioning in the intended healthcare environments, ultimately improving patient outcomes and advancing healthcare solutions.

Services We Provide For UK

• UKCA Marking Medical Devices

• UK Responsible Person for Medical Device

• MHRA Medical Device Registration

• Medical Device Clinical Evaluation

• Medical Device Risk Management

Our medical device services cover a wide array of products, including reusable medical devices, medical equipment, disposables, implants, drug-device combination products, and home healthcare devices. We cater to all device classes, ensuring compliance and regulatory support across a diverse range of medical indications. Whether it’s for high-risk devices like implants or low-risk items like disposables, we provide comprehensive consultation, certification, and regulatory guidance tailored to each device’s unique requirements. Our expertise spans the entire lifecycle of medical devices, from design and development through to post-market surveillance, ensuring that all products, regardless of their type or complexity, meet the necessary regulatory standards for safety, efficacy, and performance. This includes support for class I, II, and III devices, as well as combination products that involve both drug and device components, offering our clients the confidence that their products are compliant with relevant global regulations. Furthermore, we also assist in navigating the growing sector of home healthcare devices, helping manufacturers ensure these products meet the standards required for safe and effective use in non-clinical settings.

Services We Provide

• Medical Device Establishment Registration

• MDSAP Certification

• Annual Maintenance Contract for Medical Device

• Medical Device Turnkey Services

• Medical Device Quality Audit

• MRM for Quality Management

• Training for CE Marking

• Medical Device Process Validation

• Medical Device Quality Management System

• ISO 13485 Certification

• ISO 9001 & ISO 13485 - IQMS