The In Vitro Diagnostic Regulation (IVDR) transition will bring positive changes to European Union (EU) regulation of medical devices and laboratory-developed tests (LDTs). But it also presents potential obstacles. Fortunately, Thermo Fisher Scientific can help you conquer these roadblocks quickly. We’ll help you ensure compliance, supply consistency, validation, and scalability, all while offering the clarity and confidence you need for your IVDR transition.
We are committed to supporting all our customers during this transition phase. If you have any questions or would like to learn more about IVDR, read our blog, Getting Ready for the IVDR.
Below are offerings to support IVDR compliance
1. Analytical validation consulting services—assistance to meet demanding quality requirements
Molecular testing laboratories face several challenges when introducing new assays. One critical, time-consuming, and costly challenge is planning and executing the analytical validation (AV) process—a requirement of process validation.
Fortunately, Thermo Fisher Scientific has decades of experience in designing, building, testing, and supporting validated systems, in compliance with applicable standards and regulations. Whatever level of service you require, we are the right choice to help shorten your validation time, control your validation cost, and facilitate your compliance with regulatory requirements. Managed by a validation specialist and with the support of an analytical application consultant, our validation services help accelerate the onboarding of new assays and assist in adhering to quality standards.
Onboarding an IVD assay, unsure about the AV process, or need an assay bridging solution?
Consider starting with a verification evaluation. Our analytical performance verification (APV) solution service helps save you time and reduce costs by verifying an IVDR assay workflow in your laboratory and determining whether your workflow is ready to move to a complete AV. It can also provide verification of wet lab changes to your assay workflow.
Guided by a technical project manager and experienced validation specialist, the APV service enables you to evaluate your workflow on a controlled scale, and it helps you meet compliance.
Onboarding an IVD assay, need assistance in meeting regional validation requirements?
Our AV consulting services are flexible and adapt to regional validation requirements. The analytical validation regional (AVR) service is designed to follow regional requirements, guided by a technical project manager and experienced validation specialist. This takes you through an AV process tailored to fit your region.
The IVDR presents new regulatory challenges but puts greater emphasis on quality. Our AV consulting services provide the guidance, materials,* and support to help you complete the AV faster. This process enables you to meet ISO 15189 quality guidelines.
|Analytical Performance Verification (APV) Solution||Analytical Validation Regional (AVR) Service|
2. Manage your analysis pipeline with bioinformatics consulting services
Our bioinformatics consulting services will customize your experimental design* and optimize workflows to get the most from systems and software.
Our services are designed for all experience levels, and our informatics specialists will help take the worry out of data analysis by providing software and programming tools consulting, dataset interpretation, application training, and complete end-to-end solutions support with:
- Ion AmpliSeq™ gene panel optimization
- Exome sequencing
- Variant annotation
- Plasmid identification
- De novo transcriptome sequencing
- 16S metagenomics
- Relational databases (MySQL™ software)
- Programming languages (e.g., R, Perl™, Python™ languages)
*Bioinformatics consulting services are only available for Next-Generation Sequencing (NGS) workflows.
3. Keep your IVD instruments compliant with instrument hardware qualification services
Our manufacturer-trained and certified field service engineerswill conduct and document comprehensive tests, includingsoftware and hardware compatibility matrixing, componentverification, and site requirements. This helps verify performance,providing reliable, audit-style documentation to meet yourregulatory requirements.Installation qualification (IQ), operational qualification (OQ),and performance qualification (PQ), also known as instrumentperformance verification (IPV) services, to verify and document yourinstrument’s ability to meet manufacturer design specificationsfor performance.
- IQ—provides documented evidence and verification that the instrument has been delivered and installed according to the manufacturer’s specifications
- OQ—provides documented verification that the instrument subsystems are operating as designed; verifies that the functionality of an instrument meets the manufacturer’s operational specifications
- PQ or IPV—provides documented verification that the instrument system can perform effectively and reproducibly within performance specifications; helps ensure confidence in results by verifying that the accuracy and precision of an instrument is maintained
4. Maximize your instrument uptime with superior services and support
AB Platinum Service Plan
AB Platinum Service Plan raise your testing confidence even higher with our premium service plan* that promises the total lab support you need to deliver reliable patient results. This service plan is ideal for clinical and IVD laboratories, and its enhanced features include rapid-response, on-site support, Priority Technical Support, comprehensive repair coverage, planned maintenance, digital remote support, qualification services, training by a field application scientist (FAS), and a 98% uptime guarantee.**
AB Assurance Dx Service Plan
The AB Assurance Dx Service Plan is exclusively for CE-IVD instruments and designed to maintain instrument performance to help ensure availability of critical instrument systems in your workflow. This plan will help keep your laboratory operations running smoothly with planned maintenance, proactive instrument monitoring (where available), and, should your instruments require service, a timely response. Service and instrument hardware qualification documentation are provided as supporting proof of instrument performance and maintenance history for customer Quality Management Systems (QMS).
Learn more at thermofisher.com/instrumentservices
* Available for selected Thermo Scientific KingFisher and Applied Biosystems instruments. Application support offered for customers using our EUA, IVD, or CE-IVD approved workflows; limited application support for non-regulated RUO or LDT workflows.
**Terms and conditions apply. For complete details, go to thermofisher.com/uptime
For In Vitro Diagnostic Use.