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.

QMS Maintenance Contract
We have come up with a solution to free you from the rigor of constantly maintaining and updating technical files.

Biological Assessment Service
We have in-house competency to provide services of biological risk assessment.

Design and Development
We at Alceon can provide you with the support to maintain your design and development files, even retrospectively using our subject-matter experts.

Post Market Surveillance
Our team consists of experienced PMS experts, Medical Writers, Data Scientists, and Biostatisticians to carry out the activities that can overwhelm the best of teams in an organization!

Clinical Research
We at Alceon can provide you with the support to maintain your Quality Assurance & Regulatory Affairs functions exactly as the regulatory agencies need them to be maintained.

Regulatory Affairs Support
Our team consists of experienced professionals who have worked in medical device companies spanning
multiple devices such as cardiac, orthopedic, wound care and general clinical use.

Quality Assurance
The QA function performs immensely critical duties in medical device companies which are all subjected to scrutiny by a variety of regulatory agencies. For many of them it becomes a do-or-die situation for the sustenance of their business.

Internal Audit
Streamline your operations and enhance compliance with our expert internal audit services. We tailor assessments to your unique needs, ensuring efficiency, accuracy, and regulatory adherence.

Training
We can provide you both online and onsite training on a variety of subjects concerning regulatory and quality assurance/control.

Regulatory Fillings and Registrations
Navigating the intricate landscape of regulatory filings and registrations can be daunting. At Alceon Medtech Consultancy, we’re your trusted partners, simplifying the process and ensuring compliance. Let us handle the complexities while you focus on innovation and growth.
Blogs
MedTech Regulatory Insights Feb 2025
MedTech Regulatory Insights January 2025
STATISTICS 101: TYPES OF DATA
STATISTICS 101: TYPES OF DISTRIBUTIONS
WHO Prequalification of In-Vitro diagnostics
REPROCESSING OF REUSABLE MEDICAL DEVICES: INTRODUCTION
Blog on Biomaterials
ARE YOU READY TO MOVE TO ELECTRONIC IFUs?
GOOD DOCUMENTATION PRACTICES
AN INTRODUCTION TO MEASUREMENT SYSTEM ANALYSIS
REPROCESSING OF REUSABLE MEDICAL DEVICES: WORST-CASE SELECTION
Understanding the ISO 80369 Standards for Medical Connectors
Clinical-evaluation-of-medical-devices-III
Usability-Evaluation-of-Aseptic-Presentation
An introduction to the IEC 60601 standard.
HOW TO PERFORM USER RESEARCH?
COMPLIANCE WITH ELECTRONIC IFUs
National Policy in R&D and Innovation
HOW TO CREATE A DESIGN HISTORY FILE FROM SCRATCH!
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.
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