Maven

Our Services

OUR PRACTICE AREAS

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.

  • Europe
  • India
  • USA
  • UK
  • Others

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.

Services We Provide For Europe

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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.

Services We Provide For India

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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.

Services We Provide For USA

Read More

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.

Services We Provide For UK

Read More

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.

Services We Provide

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Meet us at FIME, 19-21 June 2024,
Miami Beach Convention Center, Miami, Florida

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Our Company Profile

About Us

WHO WE ARE

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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40+

Annual Maintenance
Clients

100+

Medical Devices Quality Management System

50+

CE Certification

30+

US FDA 510(k)

What Our

CUSTOMERS ARE SAYING

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Error free submission. Expert advice. Cost-Effective rates

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Our Blogs

LATEST NEWS

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Maven ProfservJune 13th, 2024

Understanding the Premarket Notification...

What is Premarket Notification 510(k)? A premarket notification...

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Maven ProfservJune 6th, 2024

Key Components Of Clean...

What is a clean room? Hi there! You...

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Maven ProfservMay 16th, 2024

Navigating Regulatory Challenges For...

Introduction Drug-device combination solutions are a major advancement...

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Presence On Every Countries

WE ARE GLOBAL

MAVEN 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.

350+

Projects in...

20+

Countries
WE ARE GLOBAL
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