We provide consultation for Medical and In-vitro Medical Device CE, US FDA, NIOSH, ISO, and Indian MDR certification along with services like Appointment of Authorized Representative, External testing services, EUDAMED registration, UDI Labelling, Registration on Sugam portal, Country registrations, Internal Audits, Management Review Meetings, Training, GAP analysis & audits, Mock audits, Conformity assessment, Document review, and Audit NC closures. For clients who face limited challenges in specific documentation, we also provide a customized service of preparing individual documents or parts of it. Our training & consulting support helps medical device customers to design & manufacture their products in compliance with regulatory requirements and bring them to the market more quickly, effectively & efficiently.
Medical Device service covering reusable medical devices, equipment, disposables, implants, drug-device combination products, and home healthcare devices across all classes spanning a diverse range of indications.
Medical Device service covering reusable medical devices, equipment, disposables, implants, drug-device combination products, and home healthcare devices across all classes spanning a diverse range of indications.
Medical Device service covering reusable medical devices, equipment, disposables, implants, drug-device combination products, and home healthcare devices across all classes spanning a diverse range of indications.
Medical Device service covering reusable medical devices, equipment, disposables, implants, drug-device combination products, and home healthcare devices across all classes spanning a diverse range of indications.
Medical Device service covering reusable medical devices, equipment, disposables, implants, drug-device combination products, and home healthcare devices across all classes spanning a diverse range of indications.
Your expert guide in the Medical Device Fraternity Maven Profcon Services LLP is a leading consultancy in the medical Device Fraternity. We provide a unique consulting experience to medical device manufacturers. We take pride in having a very dedicated, compassionate & professional team to serve you. Our technical expertise & fluency in regulatory requirements and improvement methodologies allows our customers to boost performance while safeguarding their regulatory compliance for their medical devices.
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Clients
Medical Devices Quality Management System
CE Certification
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.
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Read MoreMAVEN has a presence on every continent, with 300+ Clients in 20+ countries across the world. Our clients range from globally recognized brands to small, local businesses.
We routinely provide medical device training and consultancy services to the top medical device manufacturers around the globe and have authored the highly rated ‘Guidebook Series’ to assist medical device manufacturers in complying with the EU MDR and IVDR.
