QMS Services
See how Regs by Karen Ltd can help you build and maintain the right QMS.
Quality Management Systems
Regs by Karen Ltd provides practical, hands-on support to help manufacturer's establish, maintain, and optimise a Quality Management System that is robust, efficient, and fully aligned with ISO 13485 as well as the relevant requirements of the UK and EU MDR.
Whether you need a full system build, targeted updates, or ongoing compliance checks, help is provided via gap assessments and process streamlining, as well as implementing changes driven by new regulations, standards, and guidance. This includes support with Unique Device Identification (UDI), document control and risk management integration, all to ensure your QMS is not only compliant but also works effectively for your organisation.
Risk Management
Effective risk management is central to ensuring the safety and performance of medical devices throughout their lifecycle. Regs by Karen Ltd supports manufacturers in developing and maintaining risk management processes that not only meet ISO 14971 and related regulatory expectations but also add value to the organisation.
From initial risk analysis to ongoing review and control, providing clear, practical guidance to help you build robust, compliant systems that integrate seamlessly with your overall quality and regulatory framework.
Contact me today
Whether you have a question about my services, need assistance with a specific regulatory challenge, or simply want to learn more about how I can help you achieve compliance and market success. Book a free 30 minute Discovery Call or send a contact request today.
Discovery Call Contact