Your strategic partner in In Vitro Diagnostics
Regulatory, quality, performance and post-market support for IVD manufacturers, across every product type and IVDR risk class, from assays and reagents to instruments, software and companion diagnostics.
IVD segments we support
Instruments, reagents, controls, calibrators, assays and software, in each of these diagnostic areas.
Four risk classes, four levels of scrutiny
Many devices self-certified under the IVDD now need a Notified Body. Reclassification is usually the first piece of work we do with an IVD client.
| Class | Risk profile and examples | Notified Body involvement | Key documents |
|---|---|---|---|
| Class A | Low individual and public health risk. General laboratory products, instruments, specimen receptacles | Self-declaration. Notified Body for sterile Class A only | TD · PER · PMSR |
| Class B | Moderate individual risk. Devices not covered by other rules, some self-tests such as pregnancy and cholesterol | QMS assessment with technical documentation sampling | TD · PER · PMSR |
| Class C | High individual or moderate public health risk. Companion diagnostics, cancer markers, genetic testing, STIs | QMS assessment and technical documentation assessment by generic device group | TD · PER · SSP · PSUR |
| Class D | High individual and public health risk. Blood, tissue and transmissible agent screening, blood grouping | Full assessment, EU reference laboratory testing and expert panel where applicable | TD · PER · SSP · PSUR |
How the performance documents connect
The PEP sets the method. Scientific validity, analytical performance and clinical performance each produce a report, and the PER brings them together into the conclusion your technical documentation and post-market plan depend on.
Five phases, with the IVDR deliverables built in
Engage us for a single phase or across the programme. Each phase closes with a design review and the documents your technical file will need.
Initiate & plan
Describe the device, intended use and markets; plan development, timeline and resources.
- Design & development plan
- Regulatory plan
- Scientific validity report (SVR)
- State of the art
Develop
Define functional requirements, control risks, qualify suppliers and plan verification.
- Risk management plan and analysis
- Specifications and drawings
- Design verification plan
- Performance evaluation plan (PEP) and CPSP
Verify
Test prototypes against requirements and trace outputs to inputs.
- Process validation plan
- Design validation plan
- Analytical performance report (APR)
Validate & transfer
Confirm the device meets user needs and the design transfers into production.
- Clinical performance report (CPR)
- Performance evaluation report (PER)
- Risk management report and traceability
- Technical documentation and GSPR, SSP
Commercialise
Complete submissions, labelling and training, then monitor the device in use.
- Labelling and user training
- PMS plan and PMPF plan
- PMSR (A, B) or PSUR (C, D)
- Complaint handling and vigilance
From assay development to sustaining engineering
Scientific and engineering support alongside the regulatory work, so the studies that generate your performance evidence are designed with the IVDR and FDA reviewer in mind.
- Analytical and bioanalytical method development
- Assay format selection and vendor qualification
- Internal assay standards
- Raw material and in-process testing
- Assay optimisation and cost reduction
- Proof-of-concept, sample suitability and pilot studies
- IVD prototypes
- Accuracy and precision
- LoB, LoD and LoQ
- Analytical sensitivity and specificity
- Linearity, measuring range and sample matrix
- Interference and carry-over
- Reference range
- High-dose hook effect
- Study plans per CLSI, ICH and USP
- Protocol design
- Site selection and qualification
- Study initiation and monitoring
- Ethics committee approvals and licences
- Data management and biostatistics
- Diagnostic sensitivity and specificity
- Method comparison and clinical cut-off
- Study reports
- Critical component change and stability studies
- Benchmarking and correlation studies
- Reliability: HALT, HAST and prediction
- Design transfer, process improvement and fixtures
- Software verification, validation and sustenance
- Packaging graphics, labelling and localisation testing
- Product stewardship
- Classification and lifecycle requirements
- Submission approach
- Gap assessment and remediation
- Standards assessment
- Meta-analysis and clinical decision support
- QMS compliance
EU IVDR and global market access
IVDR transition & CE marking
- IVDR gap analysis of products and files
- Reclassification from IVDD to Class A–D
- GSPR checklist against Annex I
- Technical documentation drafting and remediation
- EUDAMED registration and UDI label updates
Notified Body & representative
- Notified Body selection by designation scope
- EU Authorised Representative research, shortlist and appointment
- Mock IVDR audits and Notified Body query responses
- PRRC training and file mentoring for your staff
Performance evaluation
- PEP, SVR, APR, CPR and PER
- Clinical performance study plans and reports
- SSP for Class C and D devices
- PMPF plans and reports
United States
- 510(k), De Novo and PMA
- CLIA waiver applications
- Emergency Use Authorization
- IDE and Device Master Files
- BLA support for CBER-regulated IVDs
China, Canada & RoW
- NMPA classification, registration and legal agent coordination
- Health Canada MDL and MDEL, MDSAP
- ANVISA, TGA, MFDS, GCC, ASEAN, LATAM and Africa
- Renewals, change notifications and ad-promo review
IVD quality systems
- ISO 13485 QMS designed for IVD manufacturing
- Risk management to ISO 14971
- Stability per ISO 23640 and CLSI EP25
- Supplier audits and internal audit programmes
Discuss your device, market or audit with a specialist
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.