Medical Device Compliance
ISO Sense offers a comprehensive range of support for medical device companies to meet their quality assurance and regulatory needs. With years of experience in the medical devices and IVD sectors, we understand the complexities of the regulatory landscape necessary for successfully marketing these critical products.
The medical device regulatory framework is undergoing significant changes, particularly in the EU, where the Medical Devices Regulation (2017/745/EU) and the In-vitro Diagnostic Medical Devices Regulation (2017/746/EU) impose substantial new requirements and alter conformity assessment processes for many products. With these regulations already in effect for new products and the transition deadline for existing CE-marked products approaching, timely preparation is essential to ensure product supply continuity.
Post-Brexit, new interim regulatory requirements have been established for the UK market, including the introduction of the UKCA compliance route. As the UK develops its new medical device regulatory framework, it is important for manufacturers and stakeholders to seek expert guidance to effectively navigate the evolving regulatory commitments.
ISO Sense provides the following services to assist new and existing medical device manufacturers and supply chain stakeholders in managing compliance obligations:
Quality Management System
Initial development and implementation
ISO 13485 gap assessment and remediation
Regulatory gap assessment and remediation
Technical Documentation
Guidance through the design and development process
Preparation of documentation and regulatory submissions for CE marking and/or UKCA marking
General Support
Development of domestic and international regulatory strategy
Notified Body and UK Approved Body assessment readiness audits
To discuss these services or any other regulatory needs related to your medical devices, please get in touch with us.