ISO 13485 Accredited Experts in Diagnostic Test Kit Assembly & Fulfilment
Medical device guidelines
What is Medical Device?
Medical device is any instrument, apparatus, implement, machine, appliance, software, implant, reagent, or material used to diagnose, prevent, monitor, treat, or alleviate a disease, injury, or medical condition. Medical devices cover a wide range of products used in healthcare settings, ranging from simple tools like bandages to complex machinery like MRI scanners.
Medical devices in the UK are regulated to ensure they are safe and effective for use. Following the UK's exit from the European Union (EU), there are new regulations and guidelines specific to the UK market. Here's an overview of the UK medical device regulations and guidelines:
Governing Bodies in the UK
Medicines and Healthcare products Regulatory Agency (MHRA): The primary regulatory body overseeing medical devices in the UK.
UK Conformity Assessed (UKCA) Mark: This mark indicates conformity with UK regulations, replacing the CE mark for the UK market.
Key Characteristics of Medical Devices
Purpose: Medical devices are designed for specific healthcare applications, such as diagnosis, treatment, prevention, monitoring, or rehabilitation.
Regulation: Medical devices are subject to strict regulatory standards to ensure they are safe and effective. In the United States, they are regulated by the Food and Drug Administration (FDA); in the UK, by the Medicines and Healthcare products Regulatory Agency (MHRA); and in Europe, by the European Medicines Agency (EMA).
Classes: Medical devices are categorized into different classes based on risk level. Class I devices are generally low-risk, while Class III devices are high-risk, requiring more rigorous testing and regulatory approval.
Types of Medical Devices
Diagnostic Devices: Tools used to identify diseases or conditions, such as blood glucose meters, X-ray machines, and MRI scanners.
Therapeutic Devices: Instruments used for treatment, including pacemakers, defibrillators, and infusion pumps.
Surgical Instruments: Tools used in surgical procedures, such as scalpels, forceps, and retractors.
Rehabilitation Devices: Equipment used in physical therapy or rehabilitation, like crutches, wheelchairs, or prosthetics.
In Vitro Diagnostics (IVD): Reagents or equipment used to test biological samples outside the body, such as blood tests and DNA sequencers.
Regulation and Compliance
Medical devices must comply with specific regulatory requirements, which vary by country or region. These regulations ensure that devices are safe and effective for their intended use. Compliance typically involves:
- Conformity Assessment: A process to ensure that a medical device meets regulatory standards, often involving a Notified Body or Approved Body.
- Clinical Trials and Investigations: Some devices require clinical studies to prove their safety and effectiveness.
- Post-Market Surveillance: Once a device is on the market, manufacturers must monitor its safety and report any adverse events to regulatory authorities.
Importance of Medical Devices
Medical devices play a critical role in modern healthcare. They enable early diagnosis, provide life-saving treatments, and improve patient outcomes. From everyday tools like thermometers to life-saving equipment like ventilators, medical devices are essential in medical practice and patient care.
Let us join your journey
At Nexus BioLink, we are here to support you throughout your entire medical device journey. Contact us to learn more about how our solutions can meet your needs and see why we're a trusted partner in the industry.
Key benefits of working with us
Quality and Compliance
We are ISO 13485 certified for the manufacturing, storage, and fulfilment of medical devices. Our dedicated quality and compliance team is equipped to support your business across all regulatory requirements, including IVD, MDR, UKCA, and CE marking.
Compliance is the foundation of everything we do within the diagnostics industry. Our team
We are ISO 13485 certified for the manufacturing, storage, and fulfilment of medical devices. Our dedicated quality and compliance team is equipped to support your business across all regulatory requirements, including IVD, MDR, UKCA, and CE marking.
Compliance is the foundation of everything we do within the diagnostics industry. Our team provides expert guidance on a wide range of technical aspects, including:
- Biological evaluations
- Technical file preparation
- Quality Management Systems (QMS)
- Post-market surveillance
With patient safety at the heart of our work, we ensure your products remain fully compliant, reliable, and ready for market — giving you confidence at every stage of development and distribution.
Manufacturing
At our company, manufacturing devices for clients means prioritising quality, compliance, and efficiency. We begin by collaborating with clients to understand their specific requirements and design needs.
After the design is approved, our production team uses advanced techniques and cutting-edge equipment to manufacture high-quality devi
At our company, manufacturing devices for clients means prioritising quality, compliance, and efficiency. We begin by collaborating with clients to understand their specific requirements and design needs.
After the design is approved, our production team uses advanced techniques and cutting-edge equipment to manufacture high-quality devices. Our quality control experts rigorously inspect and test each product throughout the process, ensuring it meets or exceeds industry standards. This thorough approach guarantees top-quality results every time.
Smart Technology Integration & Fulfilment Solution
Smart Technology Integration & Fulfilment Solution
Our in-house technology team can integrate with any portal system to streamline both assembly and fulfilment. We develop custom coding solutions tailored to your business requirements, ensuring seamless alignment with your operations.
Whether you need a bespoke fulfilment platform or advanced data exchange capabilities, we work closely wi
Our in-house technology team can integrate with any portal system to streamline both assembly and fulfilment. We develop custom coding solutions tailored to your business requirements, ensuring seamless alignment with your operations.
Whether you need a bespoke fulfilment platform or advanced data exchange capabilities, we work closely with your team to deliver the right solution. Our systems support API and FTP integration for secure, efficient, and real-time data transfer.
In addition, our live ordering system gives you full visibility and control — allowing you to track orders, manage inventory, and optimise workflows with ease.
In-house printing and design
Smart Technology Integration & Fulfilment Solution
Custom Packaging & Print Solutions for Diagnostics.
We offer a complete design and print service tailored to your packaging needs. Our capabilities include solid and corrugated board printing, product labelling, folding instruction leaflets, bespoke ADR & IATA bags, urine cups, and UN3373 envelopes.
With over a decade of experience in prin
Custom Packaging & Print Solutions for Diagnostics.
We offer a complete design and print service tailored to your packaging needs. Our capabilities include solid and corrugated board printing, product labelling, folding instruction leaflets, bespoke ADR & IATA bags, urine cups, and UN3373 envelopes.
With over a decade of experience in printing and customised packaging solutions, our team specialises in creating bespoke, compliant, and high-quality products that support your business and ensure safe, reliable delivery of diagnostic kits and medical devices.
Stock and Inventory system
Stock and Inventory system
Stock and Inventory system
As partners of a leading global supplier of medical diagnostic components, we offer access to more than 10,000 consumables — from sample tubes and swabs to advanced analysers. If you need a bespoke diagnostic item manufactured, our expert team can guide you through the entire process, ensuring quality, compliance, and efficiency at every
As partners of a leading global supplier of medical diagnostic components, we offer access to more than 10,000 consumables — from sample tubes and swabs to advanced analysers. If you need a bespoke diagnostic item manufactured, our expert team can guide you through the entire process, ensuring quality, compliance, and efficiency at every step.
We also provide secure storage and inventory management solutions, enabling you to monitor and manage your goods remotely with ease. Our tailored systems ensure full visibility, traceability, and reliability across your supply chain.
Shipping
Stock and Inventory system
Stock and Inventory system
Through our extensive network of postal and transportation companies, we can help you reduce shipping costs. We can send pallets from our facilities to anywhere in the UK with next-day service, or to destinations around the world with just a few clicks. Our team can assist with freight handling and ensure all documentation is correctly prepared for importing or exporting goods.
Connecting with labs
Stock and Inventory system
Connecting with labs
Our in-house tech team can support API connections with laboratories, helping you integrate seamlessly with the services you need. We provide fully customised solutions across a wide range of testing kits, including:
- Home blood test kits
- Clinical blood test solutions
- DNA and genetic test kits
- Health screening kits
- Saliva collection ki
Our in-house tech team can support API connections with laboratories, helping you integrate seamlessly with the services you need. We provide fully customised solutions across a wide range of testing kits, including:
- Home blood test kits
- Clinical blood test solutions
- DNA and genetic test kits
- Health screening kits
- Saliva collection kits
- Faecal collection kits
- …and many more tailored diagnostic solutions
With our expertise in custom development, compliance, and integration, we ensure your test kits are reliable, user-friendly, and ready for market.