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.Â
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.
