About Us

Regulatory Excellence

We have a passion for quality in the services we offer.

Who We Are

Specculo is a consulting firm specialising in regulatory affairs and quality management systems related to medical devices and IVDs in the EU and UK.

Our Mission

Specculo strives to provide the medical device industry with high quality regulatory consulting services.

Kenneth

Kenneth Shaw

Director | Executive Consultant

Throughout his experience in the industry, Kenneth has guided hundreds of medical device and IVD manufacturers to succeed in both the EU and UK markets.

He founded Specculo to provide high-quality and professional consulting services to manufacturers and other economic operators around the world. 

Kenneth applies his years of experience to guide clients through complex regulatory challenges, as well as handle delicate interactions with Notified Bodies and EU Competent Authorities.

Originally graduating with a Bachelor’s degree in Mechanical Engineering from the University of Malta, Kenneth continued his passion for medical devices by reading for a Master’s degree in Biomedical Engineering at Imperial College in London. There, Kenneth was truly immersed in the world of medical devices and, coincidentally, their regulation.

Prior to founding Specculo, Kenneth worked in a leading regulatory consultancy firm and EU authorised representative organisation where he led a team of consultants and took on the role of Management Representative and PRRC.

Why Choose Specculo?

Specculo has the experience and knowledge to ensure you are fully compliant with the EU and UK regulatory requirements for your medical devices and IVDs. Throughout their experience, our team has successfully worked on a wide range of product types including computer aided detection software, active implantable medical devices, pharmacogenomics, cardiovascular devices, and infusion pumps. From innovative to traditional medical devices, we have seen many regulatory projects to success. We also pride ourselves on offering a highly responsive service and prefer to take a friendly approach with our clients. The Specculo team understands that the regulatory requirements can be daunting. This is why we take our time to explain what is needed in a clear manner to ensure you go away with the knowledge required to maintain your compliance.

The Specculo process begins with an initial consultation from which we can understand your requirements and you can learn how our services will benefit your organisation.

Following our projects, we remain at hand to explain any documentation created and answer any questions you may have. We want to see you succeed, and we will be with you every step of the way.

We strive to be your regulatory partners in the EU and UK by providing you with advice on how to get to market and maintain compliance over the lifecycle of your products.

Simplify your compliance workflow.