Jan 23, 2013
Regulatory approvals, quality system certification and product testing certificates take significant time, effort and money to achieve. They are key assets of the company. Yet, all too often companies make no mention of their hard-won certifications or bury proof of these certifications, perhaps only mentioning them on the company’s “About Us” website page. At Emergo Group, we advise all of our clients to create a compliance page on their website and I wanted to share with you a sample regulatory compliance web page we have created. There are several good reasons to create a “Regulatory Compliance” page.
1. Listing your certificates, approvals and other regulatory compliance information in one location online makes it easy for customers, end users, distributors and regulatory officials to contact you (or your in-country regulatory representative) to request more product information or report an incident involving your product.
2. Showing this information highlights your dedication to quality and safety since you are proactively demonstrating compliance with international regulations.
3. Prospective customers evaluating your product will inevitably end up on your website and they will want to know if your product has approval in their market, with proof to back it up! This is an excellent way to show off your ISO 13485 certificate, regulatory approval certificates or FDA device listing numbers with links to the listing on the FDA website.
There are many ways to structure a regulatory compliance page. Do you have an excellent example to share? We would love to hear from you. Email us at marketing@emergogroup.com with a link to the page.
As part of a professed effort to align its regulatory practices more closely with those of Global Harmonization Task Force (GHTF) members, the US Food and Drug Administration is set to implement a
Following last week's announcement that it would implement a pilot program in June waiving FDA GMP quality system inspections for manufacturers choosing to submit recent ISO 13485:2003 audit reports, the US Food and Drug Administration has published additional explanations of how its new program will work.