In the ever-evolving landscape of medical device regulation, companies often find themselves navigating a complex maze of requirements and obligations to ensure compliance and successful market access. With the introduction of the European Union’s Medical Device Regulation (EU MDR) and In Vitro Diagnostic Medical Device Regulation (EU IVDR), the challenges faced by manufacturers have only intensified. Enter Kenneth Shaw, the visionary founder of Specculo Consulting, a firm dedicated to providing expert guidance to the medical device industry.
Extensive Industry Experience
Kenneth Shaw’s journey in the medical device sector began with a Bachelor’s degree in Mechanical Engineering from the University of Malta, followed by a Master’s degree in Biomedical Engineering from Imperial College London. This academic foundation coupled with his extensive industry experience has allowed him to cultivate a deep understanding of both the technical and regulatory aspects of the field.
Before establishing Specculo Medical Device Regulatory Consultancy, Kenneth spent years honing his expertise at a leading regulatory consultancy firm and an EU-authorised representative organisation. He took on pivotal roles as a Management Representative and Person Responsible for Regulatory Compliance (PRRC), guiding companies through the intricate maze of EU regulations and Notified Body interactions.
Launching Specculo Consulting
Driven by a passion for helping medical device companies succeed, Kenneth Shaw founded Specculo Consulting to provide high-quality regulatory consulting services to manufacturers and other economic operators worldwide. With a team of seasoned professionals, Specculo has become a trusted partner, offering comprehensive solutions that encompass regulatory affairs, quality management systems, and technical documentation services.
Regulatory Expertise and Customised Solutions
Specculo’s team boasts extensive knowledge and experience in the regulatory landscape of both the European Union and the United Kingdom. They have successfully guided hundreds of medical device and in vitro diagnostic (IVD) manufacturers through the complex regulatory challenges associated with these markets.
One of Specculo’s core strengths lies in its ability to provide customised solutions tailored to the specific needs of each client. From device qualification and classification to conformity assessment procedures and regulatory strategies, Specculo offers a comprehensive suite of services to ensure compliance at every stage of the product lifecycle.
Comprehensive Regulatory Services
Specculo’s expertise extends far beyond merely guiding clients through the regulatory process. They offer a comprehensive range of services that address every stage of a device’s lifecycle. From technical documentation development, including design specifications and risk management, to post-market surveillance and vigilance activities, Specculo provides a one-stop solution for regulatory compliance. Their services encompass crucial aspects such as clinical evaluation reports, biological evaluation reports, and unique device identification (UDI) management. By offering a holistic approach, Specculo ensures that clients are equipped with the tools and knowledge necessary to maintain compliance at every step, minimising the risk of non-conformities and ensuring smooth market access.
Technical Documentation and Quality Management Systems
Kenneth Shaw and his team at Specculo understand the critical importance of robust technical documentation in achieving EU regulatory compliance. Their expertise extends to developing meticulous technical files, risk management documentation, clinical evaluation reports, and biological evaluation reports, ensuring that every aspect of a client’s medical device is thoroughly documented.
Moreover, Specculo recognises the significance of implementing an effective Quality Management System (QMS) to maintain compliance consistently. As a result, they offer services ranging from QMS setup and amendment to internal audits, ensuring that clients’ systems are fit for purpose and meet the stringent requirements of ISO 13485:2016 and the EU Regulations.
EU Authorised Representative and Import Assistance
For non-EU manufacturers seeking to enter the European market, Specculo serves as a trusted EU Authorised Representative. This role involves verifying documentation, ensuring registration obligations are met, and facilitating communication between the manufacturer and competent authorities.
Furthermore, Specculo provides comprehensive Import Assistance services, helping importers navigate the complex web of obligations related to documentation verification, labelling, vigilance guidance, and Eudamed registration. This support enables importers to focus on their core business while ensuring regulatory compliance.
Training and Ongoing Support
Recognising the importance of knowledge transfer, Specculo offers robust training programmes to equip clients’ personnel with the necessary understanding of their obligations under the EU Regulations. These sessions cover a wide range of topics, including post-market surveillance activities, importer and distributor obligations, and the responsibilities of the Person Responsible for Regulatory Compliance (PRRC).
Specculo’s commitment to its clients extends well beyond the initial project delivery. Kenneth Shaw and his team remain available to explain any documentation created, answer questions, and provide ongoing support to help clients maintain compliance throughout the product lifecycle.
In the highly regulated world of medical devices and in vitro diagnostics, Specculo Consulting, led by Kenneth Shaw, stands as a beacon of expertise and guidance. With a deep understanding of the European and UK regulatory environments, Specculo empowers manufacturers to navigate the complexities of compliance, from technical documentation to quality management systems. Through customised solutions, comprehensive support, and a commitment to ongoing partnerships, Kenneth Shaw and his team steer medical innovators towards success across the EU and UK markets.
