Regulatory Issues

Regulatory Expertise

In the dynamic world of medical device regulations, staying ahead of the curve is crucial. Our team at Simed Global is dedicated to guiding you through the intricate process of medical device regulation. We understand the complexities introduced by the EU implementation of Medical Device Regulation 2017/745 and In Vitro Diagnostic Device Regulation 2017/746. We are here to simplify these challenges and let you focus on what you do best.

Comprehensive Services for Medical Devices and IVD

Every project has three constraints - time, cost and quality. Our goal is to bring your devices to market as quickly as possible. Time is money, and patent life-time. We are here to build a robust regulatory strategy that maintains your presence in the market. We offer comprehensive services, including:

    - Navigating Regulatory Landscapes:
    With changing regulations, we provide expert advice and support, to ensure your medical devices meet current standards and any upcoming changes to consensus and harmonised standards.
    - In Vitro Diagnostics:
    We specialise in guiding you through the process of bringing In Vitro diagnostics to market, ensuring compliance with the In Vitro Diagnostic Regulation 2017/746. This includes companion diagnostics and writing of the mandatory documents required for clinical evaluations.
    - Quality Management Systems:
    We help implement and maintain Quality Management Systems in line with ISO 13485, 21 CFR part 820, and MDSAP, adapting to new and complex regulatory requirements.
    - Software as a Medical Device:
    Our consultancy services extend to Medical Device Software and Software as a Medical Device (SaMD), focusing on compliance with IEC 62304.
    - Medical Writing:
    We ensure your compliance through the creation and updating of clinical or performance evaluation reports, necessary for the lifecycle of your device.
    - UK Responsible Person Representation:
    For non-UK manufacturers, we offer services as a UK Responsible Person (UKRP), liaising with the Medicines & Healthcare Regulatory Agency (MHRA) on your behalf.
    - Authorised Representative:
    For non-EU manufacturers, and those in the EU looking to delegate this task we offer this service as EC-REP, and are registered on Eudamed through our Dublin office.
Global Reach and Training

    - Global Registrations:
    We provide expertise for global markets, including Australia, Brazil, Canada, China, Japan, India, the Middle East, and USA. We will help you align your strategy to leverage your data to maximum effect worldwide.
    - Customised Training:
    Our training courses are tailored to meet your team's specific needs, covering topics like risk management planning (ISO 14971), ISO13485, Medical Device Regulation/In Vitro Diagnostics Regulation, and technical documentation compilation.

Your Trusted Regulatory Partner

At Simed Global, we pride ourselves on being your go-to consultancy for regulatory framework in the medical devices and IVD sectors. Our experienced team works closely with businesses of all sizes, from startups to global manufacturers, to build a regulatory framework that ensures product compliance and market success.

Get in touch with us today to navigate the regulatory pathways and bring your innovative medical devices to the market with confidence.