Emergo by UL services

For many healthcare innovators, opportunities to grow can outpace their ability to scale. Building capabilities in-house requires time and resources that many firms don’t have in the evolving commercial and regulatory demands of the healthcare industry.

Regulators in most medical device markets require registrants to meet post-market surveillance (PMS) obligations to maintain compliance. However, PMS rules can vary between different medical device markets, requiring manufacturers to develop tailored rather than one-size-fits-all approaches. With deep expertise in post-market surveillance requirements, Emergo is equipped to act as your compliance partner long after your device goes on the market. We can help you design and implement a PMS system that meets requirements in multiple markets and navigate regulatory challenges throughout the device lifecycle.

It is easy to make mistakes in the regulatory process that can delay market entry or incur unnecessary costs. With help from Emergo’s medical device RA/QA consultants, you can pursue the most efficient regulatory route to approval and registration for your device, and maintain compliance with post-market requirements worldwide.

Commercializing your medical device first requires you to obtain registration and approval from regulatory agencies in each country where you plan to sell your device. Device registration requirements can vary significantly from country to country, which can create compliance challenges for companies pursuing multiple-market strategies. Depending on where you plan to sell your device(s), successful registration may involve substantial effort to meet premarket technical and clinical submission requirements or leveraging your existing registrations and approvals to gain faster access to new markets.

Medical device regulations in most countries require foreign manufacturers to appoint an in-country representative. Your representative acts as your liaison to regulatory authorities and assists with device registrations and vigilance/adverse event reporting. It’s important to choose a representative who is familiar with the regulatory requirements for your product to act in the best interest of your company.