Introduction of Quality and Regulatory Affairs of Medical Device:
Quality and Regulatory Affairs is a profession that came from governments’ desire to protect public health by ensuring the security and adequacy of products in areas such as pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, beauty care products, and complementary medicines.
Medical equipment, pharmaceuticals, and clinical gadgets play a vital part in human existence, hence rules or regulations are necessary to ensure quality, safety, and efficacy. The Quality and Regulatory Affairs professional is solely responsible for maintaining product consistency and keeping accurate records.
What Responsibilities Quality and Regulatory Affairs Professionals Usually Have?
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- Ensure that their companies follow all applicable regulations and legislation.
- Collaborating with federal, state, and local regulatory agencies and personnel on specific issues affecting their business, such as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and medical devices); the Department of Energy; and the Securities and Exchange Commission (banking).
- Advising their companies on regulatory and climatic issues that may affect intended activity. Specifically, defining the “regulatory climate” surrounding concerns such as prescription drug advertising.
Responsibilities in Regulatory:
- Lead the creation and implementation of regulatory strategies for drug development.
- Manage regulatory schedules and prepare worldwide submissions.
- Collaborate with regulatory service providers to acquire necessary data and documentation for filing with local authorities.
Responsibilities in Quality:
- Ensure clinical trials adhere to GCP, ICH standards, EU CTD, and other applicable laws and regulations.
- Develop, maintain, and obtain senior management approval for the Quality Management project and strategic audit program.
- Establish and monitor clinical QA document systems, protocol deviations, investigations, and change control management systems/tools.
Our Quality and Regulatory Affairs Services at Glance:
- Regulatory strategy: we assist manufacturers in clinical evaluation, medical device classification, regulatory submissions, implementation of QMS
- Global submissions: Europe CE marking, FDA 510(k), experience with merging technology,
- Post-market regulatory:
Quality and regulatory affairs requirements for medical devices kick in and play a critical role from the product design phase, providing guidelines throughout the product lifecycle.
Want Comprehensive Regulatory Support for Medical Devices?
As a medical device regulatory consultant, we possess in-depth knowledge of the optimal regulatory pathways for your devices. With extensive experience working with regulatory bodies such as the USFDA, EUMDR, CDSCO, SFDA, EDA, and others, we offer comprehensive support to medical device manufacturers throughout the entire device lifecycle. Our product development services include device design and documentation, design verification and validation, risk management support, and more. We specialize in the MDR/IVDR regulatory pathways, technical documentation submissions, QMS implementation by ISO 13485 and 21 CFR Part 820 QSR, audit preparation for QMS, and post-market surveillance. Contact us today for consultancy.
