- info@omcmedical.co.uk
Get In Touch:
Get In Touch:
- info@omcmedical.co.uk
EU MDR
Staying Vigilant: Best Practices for Post-Market Surveillance under EU MDR
As medical device manufacturers navigate the landscape of post-market surveillance (PMS) under the European Medical Device Regulation (EU MDR), maintaining vigilance and adherence to best practices is crucial. Effective PMS not only ensures ongoing product safety and efficacy but also facilitates compliance with regulatory requirements. Top 7 Key Strategies for optimizing Post-Market Surveillance Here, we outline key strategies for optimizing post-market surveillance in alignment with EU MDR sta...
Manual on Borderline and Classification of Medical Devices
New guidelines on how to distinguish between medical devices and medical products under the Medical Devices Regulation have been published by a working group of the European Commission (MDR). The new recommendations from the European Medical Device Coordination Group (MDCG) cover “borderline products” that are difficult to classify as either medical devices subject to the MDR requirements or medical products for human use subject to the requirements of Directive 2001/83/EC (MPD) for CE...
MDCG Guidance for Manufacturers of Class I Medical Devices
A medical device’s intended use and inherent risks must be considered when determining its MDR classification. Class I devices pose less risk to patients and end users, as under the previous MDD. The new Regulation EU MDR 2017/745 has added extended rules, leading some devices to fall under Class IIa, IIb, or even III. This document is intended to guide Class I medical device manufacturers (excluding custom-made devices) that sell products bearing their name or trademark on the Union mar...
Software As a Medical Device and Its Clinical Evaluation
As technology advances across all healthcare fields, Software plays a significant role in all products. It is widely integrated into digital platforms serving both medical and non-medical purposes. Medical device software is one of three types of Software related to medical devices. The other two types of medical device software include Software that is an integral part of the medical device (medical device software) and Software used in manufacturing or maintaining the medical device. Software...
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If you have any questions or need help, feel free to contact with our team.
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Quick Contact
If you have any questions or need help, feel free to contact with our team.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Quick contact
- info@omcmedical.co.uk
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0044 7719761764
0044 2080667260 - Planet House, North Heath Lane, Horsham, West Sussex RH12 5QE
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our Branches
- Switzerland
- Europe (Northern Ireland)
- Asia
- Canada
- Brazil
- Middle East
- China
- Turkey (Partner Office)
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.
Our Branches
- Europe
- Asia
- Africa
- Oceania
- South America
- North America
- Planet House, North Heath Lane, Horsham, West Sussex RH12 5QE
- Planet House, North Heath Lane, Horsham, West Sussex RH12 5QE