Essenvia is an online platform to streamline regulatory pathway for medical device companies. FDA research data indicates that regulatory submissions have grown in complexity and size with an average of 1185 pages per submission, with a consistent 30% rejected at initial review and 64% sent back for additional information. Essenvia’s regulatory software streamlines the regulatory submission process by improving collaboration and automating some of the most time-consuming and error-prone tasks. Submissions processed on Essenvia reduce time and effort by 40% and eliminate 52% of errors. We are determined to reduce avoidable errors in regulatory submission and help medical device companies accelerate time to market.

More than 28,000 organizations use SafetyCulture flagship products, iAuditor and EdApp, to perform checks, train staff, report issues, automate tasks and communicate fluidly. SafetyCulture powers over 600 million checks per year, approximately 50,000 lessons per day and millions of corrective actions, giving leaders visibility and workers a voice in driving safety, quality and efficiency improvements.

Recent analysis by Forrester found that SafetyCulture’s flagship products provide a 214% return on investment for customers, and USD $3.6M in cost savings from operational improvements.

Customers of SafetyCulture’s award winning products include the likes of Shell, United Nations, Virgin Active, Cathay Pacific, Mars and BP Chargemaster.