The basics that you should know about Quality Assurance and Regulatory Consulting

by | Jan 19, 2017 | 0 comments

The basics that you should know about Quality Assurance and Regulatory Consulting

All across the globe, multiple disciplines are experiencing a lack of specialists in various fields. The medical industry is no exception, as there is a growing need for professionals who have been trained in quality assurance and regulatory consulting or regulatory affairs.

The quality assurance profession is unquestionably important in the medical sector: a quality assurance and regulatory affairs consultant ensures that medical products, devices, technology and equipment comply with government regulations and international and domestic industry standards.

Medical device companies employ such quality assurance and regulatory consultants who are in charge of monitoring every phase of product development through product branding and marketing, ensuring that the entire process meets the requirements and standards of government regulations.

Professionals in these positions must be highly knowledgeable, not only on regulatory affairs and medical procedures, but they must be extremely sensitive to global trends in quality assurance, highly experienced in corporate communications practices, and increasingly forward-thinking individuals who are able to enforce the policies and strategies that contribute to the quality and reliability of medical products produced, marketed and sold to consumers and businesses.


Any successful business produces products that are shaped by its target consumer’s needs and the consumer’s safety first.

Never has this been more important in the medical sector, especially considering the legal, professional and ethical disasters that can destroy a medical supplies manufacturer or a pharmaceuticals company that’s been discovered to have made shortcuts or production mistakes that have breached regulatory standards.

At the heart of it all, if the top management of the company is not 100% convinced that every step of product planning and development complies with standards of quality assurance and governmental regulations, something is wrong. For this reason, medical technology and equipment suppliers require the services of medical professionals who are quality assurance consultants, regulatory affairs consultants, or both.

As a result, companies often have in-house quality assurance consultants who oversee every stage of planning and medical technology development, ensuring that the medical equipment, devices and technology that they oversee is in harmony with the regulations and standards that governmental bodies have implemented.


Medical consulting firms like EAP MedTech Consulting Sdn Bhd, not only perform this role for various medical suppliers and manufacturers around Asia, but also offer training services aimed at continually improving practices in management, product policy development, compliance exercises and product testing to facilitate a responsible and highly sustainable economic environment for innovation in medical technology, products and services.

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