Quality Management Systems (QMS) Implementation:-
Assisting dental facilities in establishing QMS frameworks like ISO 9001 to improve quality control and compliance.
Product Registration and Approvals:-
Navigating the complex process of registering dental products with regulatory authorities and obtaining necessary approvals.
Documentation and Record Keeping:-
Ensuring dental practices maintain accurate and up-to-date documentation of patient records, procedures, and compliance records..
Auditing and Inspection Services:-
Conducting internal and external audits to assess compliance with regulatory standards andidentify areas for improvement.
Risk Assessment and Management:-
Identifying potential risks in dental practices or products and developing strategies tomitigate them.
Clinical Trial Management:-
Assisting in the planning, execution, and documentation of dental product clinical trials to meet regulatory requirements.
Labeling and Packaging Compliance:-
Ensuring that dental product labels and packaging comply with relevant regulations and provide necessary information to users.
Post-Market Surveillance:-
Monitoring dental product performance after they are on the market and reporting adverseevents to regulatory agencies as required.
Training and Education:-
Providing dental professionals with training on regulatory compliance, quality management, and best practices in dental care.
Global Market Access Strategy:-
Developing strategies for expanding dental product markets internationally by understanding and complying with diverse regulatory requirements.
Quality Control and Assurance:-
Implementingprocesses for monitoring and maintaining the quality of dental procedures andmaterials used in patient care.
Documentation of Adverse Events:-
Establishing systems to collect and report adverse events related to dental procedures or products.