Understanding and complying with medical device regulations in your target market is critical to the successful adoption of groundbreaking innovation. However, we know this isn’t always straightforward.
Whether you’re developing Software as a Medical Device, AI as a Medical Device or In Vitro Diagnostic (IVD) solutions, we’re here to help you bring your innovations to market swiftly and confidently.
We don’t just do standards.
We design your path to Quality and Regulatory excellence.
Understanding the regulatory requirements for market entry is an essential first step in Medical Device development. Let us guide you through the requirements.
Work with us to develop your Clinical or Performance Evaluation to support the validation of your device and prove its benefits.
Outsource your Quality and Regulatory function to 8fold to ensure continuous compliance and support to enter new markets.
Appoint 8fold as your UK Responsible Person to satisfy the requirements of the UK Medical Device Regulations post-Brexit.
Every Medical Device is unique, requiring its own quality management implementation to align with the product lifecycle. With structured processes aligned to International Standards, our experts will provide tailored implementation support to your business – not just policies and procedures.
We don’t believe in compliance silos; unlike other consultancies, we acknowledge and integrate international and market-specific compliance requirements into our Medical Device projects. We want to simplify the process of ongoing compliance to streamline market entry and accelerate adoption.
Jonathan Serjeant
Managing Director Metadvice
Edmund Broadhead
8foldGovernance is our trusted regulatory partner. We have collaborated with the team since inception to launch of Ayla, your CST Assistant, working with them to develop our quality documentation, submit our documentation in line with UKCA and meet crucial information security and product safety standards necessary for the UK market. “
Simon Nielsen
Book your free, no obligation discovery call with one of our Medical Device experts below.
