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

ISO 13485
Certificate

We are thrilled to announce that we have achieved the prestigious #ISO 13485:2016 certification!

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.

ONE DAY EU-MDR AWARENESS TRAINING PROGRAM

Recording will be available soon.

Vision

Our goal is to stand out from the competition in the regulatory consulting and training market by offering services that will satisfy clients.

Mission

constant improvement of knowledge and abilities to deliver top-notch services.Develop synergies by working with outside professionals.

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

If you’re someone who takes internal audits very seriously, then you’re not alone!

WE ARE WITH YOU, RIGHT THERE!

We believe that internal audits require great attention
to details and excellence in continuous improvement.

Our services offer fully customized approach to ensure
your organization operates at its peak potential, with
full efficiency and effectiveness.

INTERNAL AUDIT

Why choose our services?

WE OFFER

Today’s world does not
settle in mediocrity. Take
the first step towards a
brighter future for your
business! Contact us to
schedule a consultation
and discover how our
Quality Management
System Auditing Services
can revolutionize your
organization.

CONTACT

US NOW

+919925023428

www.alceonconsulting.com

EXPERTISE

Our experienced auditors are well-versed in international standards and best
industry practices, ensuring a thorough examination of your quality system. They
have worked for more than a decade with globally reputed certification bodies.

CUSTOMIZED APPROACH

We tailor our audit approach to meet your unique business needs, guaranteeing
a comprehensive evaluation of your quality system’s effectiveness and
compliance.

CONTINUOUS IMPROVEMENT

Our audits don’t stop at reporting observations; we provide actionable insights
and recommendations for continuous improvement, fostering growth and
operational excellence.

ENHANCED EFFICIENCY

We identify critical areas to streamline your operations by finding inefficiencies,
reducing waste, and optimizing processes to save time and resources.

COMPLIANCE ASSURANCE

We ensure compliance with regulatory requirements and industry standards,
giving you the confidence to navigate competitive landscape seamlessly

COST-EFFECTIVE SOLUTIONS

We offer cost-effective auditing solutions that provide outstanding value for your
investment, delivering results that exceed expectations

contact@aclonconsulting.com

LET US BE YOUR PARTNER IN QUALITY EXCELLENCE!

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