Regulatory & Consulting Services for Medical Devices

Services

Alceon medtech consulting is a regulatory consulting organization providing services to medical devices and in-vitro diagnostic device manufacturing companies. We are ISO13485 certified and manned by professionals with extensive experience of working at EU Notified Bodies and global medical device and diagnostic companies. We provide the following services:

Advise and mentor manufacturers on regulatory pathways
Preparation of complete dossiers for regulatory submissions as per requirements of different countries
Design, conduct and report clinical trials (for medical devices) and performance
evaluations (for IVD devices), both pre-market and post-market
Provide support on Quality Assurance activities including conducting internal and supplier audits, conduct investigations and root cause analysis of complaints and non-conformities, propose corrective and preventive actions
Assist manufacturers to implement Quality Management Systems including preparation of documents, training, and helping to implement on the ground. This includes Quality Systems such as Schedule V of the Indian Medical Device Regulations, ISO13485 and country-specific systems such as MDSAP

Prepare clinical evaluation plans and reports, risk management documents, usability reports, post-market surveillance reports, biological evaluation plans and reports.
Provide training on subjects of interest pertaining to medical device regulations

QMS Maintenance Contracts

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

Biological Assessment Service

Our team for biosafety evaluation is led by a highly qualified doctorate in toxicology with more than a decade of experience in this area.

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 design and development files, even retrospectively using our subject-matter experts.

Quality Assurance Support

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

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.

Training Service

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

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.

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.

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.