Understanding About The Quality And Regulatory Affairs Of Medical Devices

Quality And Regulatory Affairs

Quality and Regulatory Affairs is a profession which has created from the desire of governments to protect public health, by controlling the security and adequacy of products in regions including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, beauty care products and complementary medicines. 

As medical devices, medicines or any clinical gadgets play a vital role in human\’s life there must be guidelines or regulations for these products or medical devices guaranteeing Quality, Safety and Efficacy. The Quality and Regulatory Affairs professional is the one in particular who is totally responsible for holding products in consistence and keeping up all the records. 

What Responsibilities Quality and Regulatory Affairs professional usually have? 


• Ensuring that their companies comply with all of the regulations and laws pertaining to their organization. 
• Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business, i.e., working with such agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and medical devices); The Department of Energy; or the Securities and Exchange Commission (banking). 
• Advising their companies on the regulatory aspects and climate that would affect proposed activities. I.e. describing the” regulatory climate” around issues such as the promotion of prescription drugs. 

Responsibilities in Regulatory: 
• Act as the regulatory key representative, developing and implementing the regulatory strategy according to the drug development. 
• Establish and manage regulatory timelines, leading the planning and preparation of global regulatory submissions. 
• Management of regulatory service providers by gathering all data and documents required to prepare and file Regulatory submissions with local authorities. 

Responsibilities in Quality: 
• Ensure requirements to operate and perform clinical trials according to GCP and ICH guidelines/ EU CTD and other applicable laws and regulations are met. 
• Develop, maintain and get senior management endorsement of the Quality Management project and strategic audit program. 
• Implement and manage clinical QA documents’ system, protocol deviation, investigations and change control management systems / tools. 

Our Quality and regulatory affair 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:  

Why choose operon strategist? 

As medical device regulatory consultant we know the best regulatory pathways for your devices. We have extensive experience of working with USFDA, EUMDR, CDSCO, SFDA, EDA and other regulatory bodies. We provide full assistance to medical device manufacturers by covering all stages of medical device lifecycle. We provide product development services like, design and documentation of device, design verification and validation, risk management support etc. we have extensive experience in MDR/IVDR regulatory pathway, technical documentation filling, implementation of QMS as per ISO 13485 and 21CFRpart 820 QSR, audit preparation for QMS and post market surveillance  

One of the vital activities of the regulatory authority is to guarantee that all the data with respect to these products or medical devices has been effectively settled with the patient, covering labelling too. Indeed, even a little mistake in any of the activities identified with Quality and Regulatory Affairs can cause the product to be recalled, in addition to the loss of several millions of dollars. 

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. 

 

Operon Strategist
+ posts
Share on:
Scroll to Top