Regulatory, Quality & Development

GBUK Group is committed to providing the highest level of service and support to its customers. Our in-house team of highly-skilled professionals are dedicated to ensuring that all standards are met and implemented to the highest degree. Our team is constantly staying up-to-date with the latest developments and trends, in order to remain at the forefront of the industry and to ensure our customers are provided with the best possible service and support.

In-House Team

Having an in-house product design & development team provides several benefits for our organisation & customers, including:

  1. Better understanding of user needs: Our in-house design team can work closely with clinicians, patients and other stakeholders to understand their needs and preferences. This can lead to the development of products that are more user-friendly and effective.
  2. Greater control over the design process: Allows GBUK Group to have greater control over the design process, from ideation to product launch. This can result in faster development timelines and greater flexibility in responding to changing user needs.
  3. Improved product quality: We can focus on creating high-quality medical products that meet regulatory standards and perform well in clinical settings. This can result in better patient outcomes and increased trust from healthcare providers.
  4. Cost savings: By having an in-house design team, GBUK Group can avoid the need to outsource design work to third-party firms, which can be expensive. Additionally, having a dedicated team can reduce the risk of costly mistakes and delays that can arise from miscommunication with external partners.

Overall, having an in-house design & development team can ensure GBUK Group create better products that meet the unique needs of their users, while also providing greater control, quality and cost savings.

Committed to Quality

ISO 13485 is an international standard for Quality Management Systems, specifically for the medical device industry. It is based on the ISO 9001 standard and is designed to ensure that medical devices meet all regulatory requirements and international standards. It is important to our company as it helps to ensure that our products are safe, reliable and effective for medical device related activities.

The standard covers all aspects of the device’s design, fabrication and performance, from the research and development phase to the production and distribution. It also requires that the company has a documented quality management system in place to ensure that the product is safe and effective for its intended use. This includes the training of personnel, preventative maintenance, calibration of equipment and the documentation of all activities related to the production of medical devices.

ISO 13485 is also important for our company as it helps to ensure that our products meet all applicable regulatory requirements. This is important to ensure that our products are safe and effective for their intended use. Adherence to the standard also helps to demonstrate to our customers that we are committed to providing the highest quality products and services.

Regulatory Standards we comply to:

MDD

The Medical Device Directive (MDD) is an EU regulation that ensures medical devices meet certain safety and performance criteria before they can be sold in the EU. The MDD is applicable to all medical devices, including those used for diagnostics, medical treatment and monitoring. The MDD is an important part of the EU’s medical device regulatory framework and is designed to protect the safety of patients and users.

UKCA

The UKCA mark is the UK’s new conformity assessment mark for goods placed on the UK market after the end of the Brexit transition period. It has been designed to replace the CE mark for goods sold in the UK. UKCA marking is required for most goods sold in the UK, including medical devices, and is essential for any organization that manufactures, designs, or distributes medical devices in the UK.

FDA

The U.S. Food and Drug Administration (FDA) is responsible for ensuring that all food and drug products, medical devices and other products available to consumers meet safety and quality standards. FDA approval is an important and necessary step in the process of bringing a product to market, and is critical to the safety and well-being of consumers.

We value your feedback

We are committed to providing you with the best possible experience. If you have any questions, comments, or concerns, please do not hesitate to contact us.

Our customer service team is available to assist you with any inquiries you may have. You can reach us via phone, email, or by filling out the contact form. We appreciate your business and look forward to hearing from you!

Call us

+44 (0)1757 288 587
Lines open
8:30 am to 5:30 pm
Monday - Friday

Deliveries

For all deliveries and collections, please park in the designated bay (HGV6) and call our number to confirm that you are in the HGV bay.

Visit us

GBUK Group Ltd.
Woodland House,
Blackwood Hall Business Park,
North Duffield,
Selby,
North Yorkshire,
YO8 5DD,
United Kingdom

Get in touch!

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