The Important Role of Medical Device Regulatory Affairs Specialists

Author: Trinity M Consulting, LLC. | | Categories: 510 K Submission , 510 K Write Up , Clinical Research Consulting Services , EU MDR , EU MDR Guidance , EU MDR Support , Medical Device Consulting Firm , Medical Writing Services , Project Management , Project Management Consulting Services , Regulatory Affairs Consulting Services , Regulatory Consultants , Regulatory Consulting Company , Regulatory Contractors , Regulatory Strategy , Talent Recruitment Consulting Services

photo-1511174511562-5f7f18b874f8-1920w.jpg

Each year manufacturing companies introduce new products into the medical device market. Worldwide, the market's value grew to $456.9 billion in 2019, and it will reach $603.5 billion by 2023.

In exchange for earning these profits, medical device companies face heightened oversight scrutiny. Regulators examine all new products at every step of development. To protect consumers, they must ensure that company products meet the required standards.

The medical device industry depends on regulatory affairs professionals. But what do they do? Learn more about medical device regulatory affairs specialists.

What Are Medical Devices and Why Are They Regulated?

Section 201(h) of the Food, Drug & Cosmetic Act defines what a medical device is. Medical devices range from simple bandaids to intricate and complicated implantable pumps.

Many medical devices save lives and improve patient comfort. They improve care in ways that we could only imagine a decade or more ago.

Medical device regulation protects patients and medical staff. Regulations ensure safety because quality standards are consistently met.

Designing a product that fails regulatory standards is a costly mistake. Medical device manufacturers do not want to restart failed projects from scratch.

Having to redesign a device is a huge waste of time and resources. To prevent this, companies hire regulatory affairs specialists to help them avoid mistakes.

What a Medical Device Regulatory Affairs Specialist Does

The role of regulatory affairs in medical device development is critical. Regulatory affairs specialists must master and communicate guidelines that apply to their industry.

They check new medical devices at each stage of development, against FDA and other agency regulations. Common stages include conceptual, preclinical, manufacturing, marketing, and ongoing industry feedback.

Regulatory affairs specialists are sometimes called quality assurance specialists. They are also known as compliance analysts, quality managers, or other titles. 

For help with complex projects, companies sometimes hire outside experts. They provide medical device regulatory affairs consulting.

A global perspective is critical for success in this role.
Medical device regulations vary by country, which has an impact on product requirements. Medical device regulation consultants understand the regulations in each country they work with.

Beyond actual product development, regulatory affairs specialists should have mastery of other skills. They must be comfortable with technical writing, data, technology, research, and legal documents.

They should also be good communicators with excellent management skills. Because they deal with many different departments, handling complexity is a necessary skill.

Our Medical Device Consulting Services

Medical device regulatory affairs specialists are an integral part of medical device manufacturing.
Our company's consultants will help your product move successfully from idea to marketing. We recruit for roles in project management, research, and technical writing.

If you are looking for a medical device regulation consultant, we would love to talk with you. We offer a free consultation to discuss how we can help your company succeed.

We look forward to hearing from you soon! Contact us today.



READ MORE BLOG ARTICLES