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MToday, medical device regulatory consultants have been playing a pivotal role in the areas of med-device development and compliance. They advise manufacturers on diverse topics on how effortlessly and sophistically, one can introduce a device to the market. This heavily regulated market needs a reliable partnership that smoothens a long, typical and complicated process that the med-device development pipeline poses.

Hence, considering the right team of experts can make a huge difference to your project and this is where Maven Profcon Services pitches in to prove its prowess. For featuring this organisation in our latest edition, we arranged a virtual meet with its Founder- Director— Mr. Yogesh Dad. In our this freewheeling conversation, he discussed various aspects of his business while also sharing some food for thought with our team. We avidly believe this exclusive read will prove to be an enjoyable and fascinating one for our global readership!

As a leading consultancy that has attained prominence across Medical Device Fraternity, Maven Profcon Services LLP oaths to become your expert guide for manufacturing regulated considering medical devices. Medical device manufacturers are in constant need of proper consulting to formulate the best-in-class solutions, where Maven offers excellence with its exemplary consulting services. Swiftly, the company has scaled greater heights owing to the dedicated efforts of its compassionate and professional team members.

Serving the clients with their technical expertise and fluency in regulatory requirements and amelioration methodologies, the organisation contributes to boosting the client’s performance alongside ensuring protection to their regulatory compliance for their respective medical devices.

Maven Profcon has become a preferred partner for more than 200 of its national as well as international clients, since its incorporation in 2016. For Indian manufacturers, it intends to help the clients meet and resonate with the global service standards whereas, for the foreign clients, Mavenguides them with its industry acumen to comply with medical device regulations of various countries.The company is well- acclaimed for its 100% client satisfaction rate where the customers are empowered by its regulatory acumen and implementation skills.

From SMEs with a small workforce to well-established MNCs with thousands of employees, the company has a clientele that encompasses both domestic as well as international clients. Irrespective of the size of the enterprises, Maven Profconpays intense heed to every client’s complex requirements and is agile, responsive and proactive to resolve their regulatory grievances. The amount of flexibility ensured by them while catering to end clients as per global timelines is absolutely commendable, which is one the major causes behind it high client contentment percent.

Bringing innovative proficiency while guiding the way for regulatory-conscious businesses across the medical device fraternity is what Maven Profcon strives for. Alongside this, it is also converged on ensuring unique customer experiences in the regulatory consultancy space that can offer a leading edge to their clientele. Their exclusive mission is driven by the idea of unveiling a local business niche while allowing easy access to international practices and while serving the unaddressed requirements of all medical device manufacturers across the globe.

Moreover, the vision with which the company is forging ahead is to be a pioneering, interactive, consumer-driven, and zealously referred, leading medical device consultancy with a dynamically evolving scope of regulatory services. With this, they aspire to deliver relevant solutions to their end customers while earning the customer loyalty of a huge portion of the population across the globe. The team at the company is fixated on incessantly exploring global trends in regulatory services while leading by example. All of the efforts put forth by the employees are to justify MAVEN’s motto of being the connoisseurs of the medical device regulatory field.’

Maven Profcon is dedicatedly involved in assisting manufacturers (Medical devices, In-Vitro Diagnostic Devices, Implantable devices, active devices, SaMD, Drug coated MDs, disposables & etc.)as per their requirements with a set of customized services globally. But, their speciality lies in the following verticals where they have been splendidly proving their prowess-

  • CE Certification- Here, Maven helps the manufacturers pass the conformity assessment with guided documentation, procedures and mock audits, to sell their respective devices across European markets. Maven provides end-to-end service from selection of notifying body, appointment of European Authorized Representative, document preparation & assessment and support during the CE Audits to Certification.
  • Compliance with Indian Medical Devices Rules- To help manufacturers introduce the medical devices across Indian Markets, Maven is adept in ensuring end-to-end services where it establishes and implements a better- quality management system, acquiring test license, manufacturing license, submitting the report on Sugam portal, facilitating audit support, and swift response to queries as per the Indian MDR.
  • Assisting in UKCA marking- To allow the medical devices to enter the UK markets, UKCA marking is required along with CE marking. Maven aids the manufacturers to transit and sync as per their evolving requirements which means helping them establish a robust UKCA conformity assessment to eradicate duplication activities.
  • Guiding through US FDA tagging- In US markets, getting an FDA- approved tag is a must to introduce a medical device to comply with USFDA regulations. Here, Maven guides you effortlessly in this direction as a US agent to get your IVD devices done with submissions/registrations/listings.

Within a short period, Team MAVEN has attained a repute obeing an assemblage of medical device regulatory experts and the elemental factor behind the thumping success of Maven Profcon Services LLP. The company has employed individuals with high proficiency in the industry giving it a leading edge. Each teammate strives to foster ground-breaking services that could prove to be significant in the customer’s success.

Addressing his team’s exemplary dedication to make the company a huge success today, Yogesh asserts, “Our ingeniously passionate and result-driven professionals make MAVEN what it is today; granting new age strategies and remarkable services to the global clientele. 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, that speak volume in our favour.”

The founding head of Maven Profcon has always acknowledged the instrumental role of an adept and motivated workforce in the exponential growth of a company. Hence, he has established some insightful cultural principles at the workstation that aid in developing and empowering the staff members to prosper to their fullest potential. Under Yogesh’s insightful guidance, the management has created a healthy as well as a competitive environment for its employees that can cultivate higher productivity, robust and scalable solutions and assured outcomes in favour of the clients.

Additionally, they also encourage their employees to maintain a healthy work-life balance for holistic growth. The administration is committed to creating processes and selections that are focused on bestowing the auditors, trainers, and consultants’ appropriate resources while facilitating them with a means to deliver superior services to the targeted audience. “We offer an open-door policy to our employees where ideas and innovations are fostered into intangible assets and delivered to the clients,” quotes Yogesh.

“We are a client relief organization, who happen to offer regulatory expertise,” claims chuckles Yogesh Dad in reference to revealing the company’s core policy dogma. The firm always prioritizes catering the finest in time medical device consultancy services that are formulated after hours of discussions and brainstorming by the Team MAVEN. The core values that inspire them to keep moving in the direction of client benefits as— Customer commitment, Integrity, Optimum quality, Confidentiality and Zest. And all their futuristic efforts will revolve around these values to scale the heights of great success.

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