As we step into the month of February, we at Patient Guard are delighted to extend our warmest greetings to you. We hope this newsletter finds you well and thriving in your respective endeavors. As always, we are committed to keeping you informed about the latest developments in the ever-evolving landscape of medical device regulatory affairs and quality assurance.
In recent months, we’ve witnessed several significant regulatory updates across various regions. Notably, the FDA’s continued efforts to streamline the regulatory process for medical devices have been commendable. We are closely monitoring the implementation of the FDA’s latest guidance documents and initiatives, ensuring our clients remain compliant and well-informed.
Additionally, the European Union’s Medical Device Regulation (MDR) continues to be a focal point for manufacturers and regulatory professionals alike. With the deadline to have a contract inplace with a Notified Body fastly approaching, compliance with the MDR standards is paramount. Our team is dedicated to guiding our clients through this process seamlessly, providing expert advice and support every step of the way.
Maintaining the highest standards of quality is fundamental to the success and reputation of any medical device manufacturer. At Patient Guard, we are committed to assisting our clients in achieving and surpassing these standards. Our comprehensive quality assurance services encompass everything from risk management and quality system implementation to post-market surveillance and audits.
As technology advances and consumer expectations evolve, staying ahead of the curve is imperative. Our team continuously evaluates emerging trends and best practices in quality assurance to ensure our clients remain at the forefront of innovation while adhering to rigorous quality standards.
Latest Medical Device Regulatory News
Latest EU MDCG Guidance Updates
MDCG 2024-1 – Device Specific Vigilance Guidence (DSVG) Template
MDCG 2024-1-1 – DSVG on Cardiac ablation
MDCG 2024-1-2 – DSVG on Coronary stents
MDCG 2024-1-3 – DSVG on Cardiac implantable electronic devices (CIEDs)
MDCG 2024-1-4 – DSVG on Breast implants
Latest Medical Device Standards issued
BS EN IEC 60601-2-21:2021+A1:2023 – Medical Electrical Equipment – Particular Requirements for the basic safety and essential performance of infant radiant warmers
ISO 11979-7:2024 – Ophthalmic implants. Intraocular lenses – Clinical investigations of intraocular lenses for the correction of aphakia
BS EN IEC 80601-2-77:2021+A1:2023 – Medical electrical equipment – Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
BS ISO 10555-7:2023 – Intravascular catheters. Sterile and single-use catheters – Peripherally inserted central catheters
BS EN ISO 17664-2:2023 – Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices – Non-critical medical devices
BS EN IEC 60601-2-19:2021+A1:2023 – Medical electrical equipment – Particular requirements for the basic safety and essential performance of infant incubators
