Alceon Medtech Consulting

AMC was founded with a mission to help our clients in the medical device and in-vitro diagnostic device sectors to navigate the complex regulatory landscape and obtain the necessary approvals to bring their products to the market.

Helping Medical Device Manufacturers to Achieve Regulatory Compliance and Market Access.

We don’t stop at just writing your documents! Our team is available to provide personalized support throughout your application process, to guide you in areas such as classification, validation, testing and to respond to queries from regulatory agencies.

Featured Services

News & Announcements

Risk Management Workshop

We successfully completed an online risk management training programme that saw overwhelming participation from several manufacturers located at different locations in the country. The training focussed on risk management as per1 the ISO14971 standard. The entire risk management proces from the identification of hazards, risk analysis, risk evaluation, taking control measures, identifying rersidual risks and conduting a risk benefit analysis was covered. Participants discussed the challenges they faced and valuable insights were provided by the experienced trainers. Contact us for your training requirements on risk management. We conduct both online and onsite trainings. Our trainings come with a lot of practical case studies which can help you build your own risk management file.

Product Launch
Alert

We are happy to announce the launch of our eQMS software – POLESTAR – A software that’s designed in collaboration with software developers and domain experts.

ORTHOFOCUS
meet up

We successfully conducted an online webinar for orthopaedic manufacturers. The webinar was conducted by experts from the field and actual manufacturers who gave their insights into aspects such as orthopaedic testing, clinical requirements, design aspects and regulatory challenges.

Our Vision

What do we want to be

To be a niche provider of regulatory consulting solutions and known for its quest for excellence

Our Mission

Deliver innovative and creative solutions that empower medical technology manufacturers to achieve regulatory compliance and drive continuous improvement

Core Values

Creativity Thinking

Have a mindset to provide creative, out-of-the-box solutions

Continuous Learning

Make continuous learning and upgradation of knowledge our best friend

Quality Consciousness

Never compromise on quality

We’d Love to Hear From You!

Whether you have a question, feedback, or just want to say hello, feel free to get in touch. Our team is ready to assist you.

Careers

WE ARE HIRING !

REGULATORY AFFAI CONSULTANTS/QMS CONSULTANTS TANTS/SCIENTIFIC WRITERS

Please apply if you want to join our vibrant team

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