Regulatory Compliance for PPE, COVID-19 IVDs and Vaccines

At the end you will need me! Do you have an innovative new device, IVD for COVID-19 quick testing or a new app? You need to CE mark all your devices before placing them on the market.

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Inspiration

During the COVId-19 outbreak many manufacturers of Personal Protective Equipment such as face masks and gowns have rushed to bring their products on the market. However many of these products do not meet the minimum safety requirements and are not CE marked.

What it does

Regulatory consulting is a service which should be taken advantage of to ensue that all products brought to the market meet the at least the Essential requirements /General Safety and Performance Requirements.

How I built it

We built the company from scratch in 2008 and over 12 years have helps hundreds of companies and innovative start-ups to CE mark their products, clinical trial applications and drug and vaccine registrations.

Challenges I ran into

Starting from scrtach and building up a good reputation in the regulatory compliance arena.

Accomplishments that I'm proud of

We have helped over 100 companies bring their products to the market.

What I learned

Patience and perseverance.

What's next for Regulatory Compliance of Personal Protective Equipment

We are looking to help all the successful EUvsVirus Hackers to bring their products to the market be it a clinical trial application for a new COVID-19 Vaccine, CE marketing new COVID-19 IVDs or making sure that all Personal Protective Equipment is properly CE marked before market entry.

Built With

  • english
  • german
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