Empowering Medical Device Success.
We cater to medical device regulatory requirements all over the world. But we take extra pride in our below services that incorporate world-wide regulatory requirements.
USFDA & 510k Submission
Empowering Your Medical Device Journey: Expert USFDA & 510(k) Submission Guidance.
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Quality Management System
Building Excellence, Ensuring Quality: Your Partner in Effective Quality Management Systems.
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Premium Organizational Management
Nurturing your Regulatory & Quality Management System for you!
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Unlocking Regulatory Excellence
Our innovative passionate and result-driven professionals make MAVEN what it is today; providing modern approaches and remarkable service to clients all over the globe. Our fairly performant team members possess vast expertise in regulatory consulting, auditing, medical device engineering, quality assurance, virtual and commercial business intelligence, and many with medical device industry experience in technical fields.
We develop and empower our staff to prosper to their fullest potential. We believe in creating a healthy and competitive environment for our employees, which aids us to achieve higher productivity with robust and scalable solutions and assured results for our clients while also ensuring an optimal work/life balance.
What We Do
We are able to ensure that your medical and IVD device complies with the relevant regulations in a timely and cost-effective manner.
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Preparation of technical documentation and regulatory dossiers.
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Pre-submission review and consultation.
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Liaison with Notified Bodies and regulatory authorities.
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Representation at regulatory authorities.
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Technical file updates and maintenance
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Obtaining declarations of conformity
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Risk management
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Post-market surveillance and vigilance
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Quality management system audits
WHY CHOOSE?
Our seasoned consultants bring in-depth knowledge of medical device regulations, ensuring your journey to compliance is guided by the best.
Industry
Expert
A versatile team of specialists with experience or educational qualifications related to medical devices who are resilient and focused.
Customized Solutions
Customized solutions while honoring client data confidentiality with timely execution and end-to-end support including visits and audit support.
Cost
Effectiveness
Our prices are competitive and fair. There are no surprise bills. Your pre-approval is required for any unexpected or additional expenses.
Quick
Support
We're more than consultants – we're your steadfast partners, providing unwavering support throughout your regulatory endeavors.
Voices of Success
Stories from Our Thriving Partners
Discover how our collaborative approach and expertise have empowered these clients to conquer regulatory challenges and drive medical device innovation forward.
Excellent service & support!!
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!
Nice work! Keep it up
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.
Great support!!
Maven's personalized approach to regulatory consultancy is unmatched. Their team not only helped us navigate complex international standards but also tailored solutions that perfectly aligned with our products' unique requirements. A truly valuable partner.
Meet Our Adept
Regulatory Maestros
Guided by experience and driven by passion, our dedicated professionals are your compass through the intricate landscapes of medical device regulations.
