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
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
Deliver innovative and creative solutions that empower medical technology manufacturers to achieve regulatory compliance and drive continuous improvement
Creativity
Have a mindset to provide creative, out-of-the-box solutions
Learning
Have a mindset to provide creative, out-of-the-box solutions
Quality Conscious
Have a mindset to provide creative, out-of-the-box solutions
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
