Maven

Our Services

OUR PRACTICE AREAS

We provide comprehensive regulatory consultation for Medical Devices and In-Vitro Diagnostic Devices, specializing in certifications like CE Marking, US FDA 510(k), NIOSH approvals, ISO 13485, and Indian MDR compliance. Our services include Appointment of Authorized Representatives, External Testing Services, EUDAMED Registration, UDI Labelling, Registration on Sugam Portal, Country-Specific Registrations, Internal Audits, GAP Analysis, Management Review Meetings, Training, Mock Audits, Conformity Assessments, Document Preparation and Review, and Audit NC Closures. For clients with specific documentation challenges, we offer customized services to prepare individual documents or sections tailored to their needs. We also assist with creating Technical Files, Risk Management Reports, Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), and Post-Market Surveillance Plans (PMSP). Our training and consulting support help manufacturers design and develop products in compliance with regulatory standards, ensuring safety, quality, and faster market access. By streamlining processes and addressing non-conformities effectively, we enable our clients to navigate complex regulatory landscapes confidently. With our client-centric approach, we aim to deliver innovative solutions that ensure compliance, minimize risks, and accelerate the time-to-market for safe and reliable products.

  • Europe
  • India
  • USA
  • UK
  • Others

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

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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

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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

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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

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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

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Meet us at ARAB HEALTH, 27-30 January 2025,
Dubai World Trade Centre

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About Us

WHO WE ARE

Maven Profcon Services LLP is a leading consultancy in the medical device industry, offering unparalleled expertise and tailored solutions to medical device manufacturers. With a team of dedicated, compassionate, and professional experts, we provide a unique consulting experience that helps clients navigate complex regulatory landscapes, ensuring full compliance with standards such as CE marking, US FDA 510(k), ISO certifications, and more. Our deep technical expertise and fluency in regulatory requirements allow us to guide clients through every stage of the process, from product development to market entry, while also focusing on performance optimization. We take pride in delivering holistic services that not only ensure compliance but also enhance operational efficiency, helping clients bring safe, effective, and high-quality medical devices to market quickly and efficiently.

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40+

Annual Maintenance
Clients

100+

Medical Devices Quality Management System

50+

CE Certification

30+

US FDA 510(k)

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WE ARE GLOBAL

MAVEN Profcon Services LLP has established a strong global presence, serving over 300+ clients across more than 20+ countries worldwide. Our clientele spans the spectrum, from internationally recognized, industry-leading brands to small, local businesses, reflecting the diverse range of organizations that trust our expertise in regulatory compliance and medical device consulting.

With years of experience, we consistently deliver top-tier training and consultancy services to some of the largest and most prestigious medical device manufacturers on a global scale. We pride ourselves on offering customized solutions that cater to the unique regulatory needs of each client, ensuring that they meet the complex requirements of markets worldwide. Our commitment to excellence has earned us a reputation as a trusted partner in the medical device sector.

In addition to our hands-on consultancy services, MAVEN has also authored the highly regarded “Guidebook Series,” which has become a key resource for medical device manufacturers navigating the ever-evolving regulatory landscape. These guidebooks, widely praised for their clarity and practicality, assist manufacturers in adhering to the stringent requirements of the EU Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR). Our ongoing efforts to support the industry ensure that our clients remain at the forefront of compliance, quality, and safety, empowering them to successfully bring their medical devices to market in a timely and effective manner.

350+

Projects in...

20+

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