Your companion from Application to Certification for
The craftsman behind your success story of achieving
Accomplices of your strategy to transit from your warehouse to
Edifying the context of your organizational
Detailing the Safety and efficacy of your devices through a robust
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.
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
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
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
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
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
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.
Read More...40+
Annual Maintenance
Clients
100+
Medical Devices Quality Management System
50+
CE Certification
30+
US FDA 510(k)
Sr. QA Executive,
Miraclus Orthotech Pvt. Ltd.
MAVEN’s Medical Device regulatory services have consistently impressed us with their technical expertise, timeliness, and tailored solutions. Their proactive approach to regulatory updates, clear communication, and effective problem-solving skills have been invaluable. Their compliance success, and training offerings have greatly benefited us. I wanted to appreciate the hard work, approach and association during audit which MAVEN team has put forward in our organization. Your regulatory support on single call is always value added.
Samay Surgical
The Maven team are ultimate rock stars! They are a highly professional, educated and experienced team that is dedicated to helping their clients achieve success. One of the best teams I have ever worked with – highly responsive, innovative and leverage best practices. From kick-off to project completion, they never miss a beat
and are always there to answer questions and provide intelligent insight. They have been consulting for ISO 13485 and CE certification. They also provide Annual Contract facility for the same. Looking forward to many more projects ahead!
Sharma Pharmaceuticals Pvt. Ltd.
We are very glad to have Maven as our regulatory consultant or you may say regulatory partner, Maven has not only eased our process but always strive for process improvements with practical approach.
Maven methodology & dedicated team for each project / client really helps in customer focus & valuable recommendations.
EON Meditech Pvt Ltd . – Technical Director
We have been using your services since 2017 and very satisfied with services. Maven has helped us to get 2 CE certificates and update QMS according to the latest regulatory requirement. We are also working with other projects like CDSCO registration and get very positive support from your team.
Working with Maven has been hassle-free and there were barely any follow-ups required. The team has always efficiently & timely conveyed all the deliverables and made sure we provide data on time and kept us on our toes which we liked about them very much. Timely arrival of required certifications and therefore enhancing our business process This led to our clients being highly impressed by the efficiency & punctuality which resulted in the completion of the project on time without any turbulence. Keep up the wonderful work & strong ethics.
Meghdoot Pharma
Maven have supported us during the time of our all regulatory needs, and that too with all the dedication and sincerity. Despite our several phone calls there has never been a voice of irritation from your side. Every problem was replied with absolute calmness and respect.
Our best wishes for your vertical growth in this field.
Hardik International Pvt.Ltd
I just wanted to let you know that “Maven Profcon Services LLP” team has been doing a tremendous job in providing best consulting services in the filed of Medical Device. They are having a big team of qualified and experienced experts to coop up and fulfill all requirements of Medical Device Directives(MDD), We appreciative all their effort and engagement in providing us the right solutions for our all requirements.
We wish them all the best for their all future assignments.
Ortho Max Mfg’ Co’ Pvt’ Ltd’
“I just wanted to let you know that your team has been doing a tremendous job on our request. They are turning things around quickly, coming up with approaches and suggestions on their own and are truly partnering with us on different initiative. We are deeply appreciative of all their effort and engagement.”
I wanted to take this opportunity and appreciate the hard work Maven team has put in getting our CE certification. This was especially challenging given short turnaround time
Pregna International Ltd
“Maven Profcon Services LLP” has been very professional in their work with us at “Pregna International Ltd.” The Team was able to quickly grasp what we wanted to accomplish and had some great ideas on how to achieve our goals through 1st official MDR training. They have a wide variety of implementation scenarios in their background that they could draw information from the demo that they put together with great example was well received. It generated a lot of interest and knowledge for the upcoming Medical Device Regulation. We highly recommend “Maven Profcon Services LLP” for any type of Medical Device Regulatory Services.
Griportho Surgicals Pvt. Ltd.
We consider MAVEN PROFCON SERVICES LLP as an associate concern of Griportho and we have always counted on you for all our regulatory requirements. We shall always admire the way your support mechanism is in place with prompt responses & correct advices.
SIA Simurg Balticum
I would like to appreciate level of service we’ve received from “Maven Profcon Services LLP” as highly professional, competent and proactive, maintaining agreed terms and at reasonable budget.
December 3rd, 2024
December 3rd, 2024
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+
Countries
