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Industry leading turnaround times in delivering medical devices, molecular and serological based reagents to the European and UK market.

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Published on
July 12, 2023
Updated on
February 6, 2023
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Access to an accredited laboratory is a vital part of the medical industry, and one that plays a key role in bringing medical devices, molecular and serological based reagents to the European and UK market. Laboratories have the capability to carry out complex research, testing, and analysis to ensure that the products they bring to market are of the highest quality and meet all necessary regulatory requirements.

One of the biggest advantages that our clinical ISO accredited laboratory can offer is its ability to provide industry-leading turnaround times for product development, validation and delivery. This is achieved via our state-of-the-art laboratory , in-house Quality Management System (QMS), streamlined Data Management processes, specimen sourcing capabilities and patient recruitment sites, as well as  and aour team of highly skilled and experienced medical and scientific personnel .  

By working closely with healthcare manufacturers and other key stakeholders, PeploBio can help accelerate the development and launch of new products and therefore expedite access to the UK market  reaching millions of patients.  

Figure 1: Our performance evaluation plans are designed to meet the IVDR requirements, with a strong focus on safety, risk, stability and generating data to support each of three key performance characteristics: Clinical Performance, Analytical Performance and Scientific Validity

In addition to its fast turnaround times, PeploBio offers a wide range of services to support the development and delivery of medical devices, molecular and immunoassay based reagents including products and reagents for HIV, Hep B and others which are classified within Part IV of the UK MDR 2002, Annex II, list A. These services include research and development, testing and validation, technical support, and regulatory compliance and certification to support the administration of the conformity assessment procedures. The laboratory uses the latest techniques to verify product quality, safety, and efficacy, and their expertise can help to minimize the risk of delays and complications throughout the product development process.

Ultimately, partnering with PeploBio offers a wide range of benefits for your market growth, offering industry-leading turnaround times, high-quality products, and expert technical support. By working closely with manufacturers and other stakeholders, we helpbring new and innovative medical devices, molecular and serology based reagents to the European and UK market, ensuring that patients have access to the latest treatments and therapies as quickly as possible.