The Medical Device Regulatory & Quality Experts.

Medical Devices

Regulatory Focused

Specculo was founded to bring high-quality and efficient regulatory services to manufacturers wishing to place their medical devices on the market. We also help other economic operators in the supply chain, such as importers and distributors, meet their regulatory obligations.

We are motivated by the success stories of our clients who are helping to improve patient outcomes and the healthcare system; whether through innovative or well-established technology.

Book a free consultation with us today or check out our services to see how Specculo can give you the edge you need to successfully comply with your regulatory obligations and requirements.

Our Consulting Services

We offer a wide range of services to cover you from the drawing board all the way through to post-market surveillance. Here are some of our core services.

Technical Documentation

Experts in building and maintaining medical devices and IVD technical documentation for EU and UK compliance.

QMS Consulting

Whether you're setting up your QMS from scratch or need to stress-test it, we've got you covered.

Import Assist

A unique service offered to importers of medical devices in the EU to assure compliance.

Training

Our training sessions are designed to address your needs and ensure your team is kept up to date on medical device obligations.

EUDAMED

EUDAMED is a complex database that can be difficult to navigate. We can obtain your SRN, register your products, and guide you through the process.

General Consulting

The EU and UK Regulations can be a hard nut to crack. We have the expertise and tools you need to help you succeed in the EU market.

Let’s Talk Regulation

Send us a message and we’ll get back to you asap.