Medical Device Regulatory & Quality Services
Support for Class I to Class III devices, implantables, active devices, software and drug-device combination products, from the first classification decision to the latest PSUR.
Devices we support
Lower-risk devices
Technical documentation and declarations of conformity, with Notified Body involvement for sterile, measuring and reusable surgical aspects.
Medium and higher-risk devices
QMS and technical documentation assessment, clinical evaluation, PSURs and PMCF built for sampling by generic device group.
Highest-risk devices
Full technical documentation assessment, SSCP, clinical investigations and clinical evaluation consultation procedures.
Active and powered devices
IEC 60601 series alignment, essential performance, EMC evidence and software lifecycle documentation.
Software and AI-enabled devices
Qualification and classification, IEC 62304 lifecycle, cybersecurity, and PCCPs for AI-enabled functions.
Drug-device combinations
Integral and co-packaged products, with GSPR evidence for the device part and coordination with medicinal product dossiers.
Typical regulatory focus by segment
Every segment has its own standards, evidence expectations and review hot spots. Ask us about our specialists' experience in yours.
Cardiovascular & neurovascular
- Class III and implantable devices
- Clinical investigations, PMCF and SSCP
- Clinical evaluation consultation procedure
Orthopaedics & implants
- Equivalence and registry-based PMCF
- Implant cards (MDR Art. 18)
- MR safety labelling and mechanical testing
Ophthalmic devices
- Biocompatibility and sterility
- Product standards such as ISO 11979 and ISO 18369
- Literature-led clinical evaluation
Diagnostic & monitoring devices
- IEC 60601 series and essential performance
- Alarm systems (IEC 60601-1-8)
- Measuring function (Class Im)
Surgical & hospital devices
- Reusable surgical instruments (Class Ir)
- Reprocessing instructions per ISO 17664-1
- Sterilisation and single-use claims
Software & AI-enabled devices
- Qualification per MDCG 2019-11, Rule 11
- IEC 62304 and IEC 82304-1
- PCCPs and cybersecurity
Drug–device combinations
- Notified Body opinion under MDR Art. 117
- Medicinal substance consultation (Annex IX §5.2)
- 21 CFR Part 4 in the US
Active & connected devices
- EMC per IEC 60601-1-2
- Wireless coexistence and cybersecurity
- Usability engineering (IEC 62366-1)
What each risk class asks of you
A simplified view of the conformity routes and recurring documents under the MDR. Your exact obligations depend on device type, rules applied and Notified Body practice; we confirm them in the strategy phase.
| Class | Typical conformity route | Recurring documents |
|---|---|---|
| Class I | Manufacturer's declaration. Notified Body for sterile, measuring or reusable surgical aspects only | TD · PMS plan · PMSR |
| Class IIa | Annex IX QMS assessment with technical documentation sampling, or Annex XI | TD · CER · PSUR (≥ every 2 years) |
| Class IIb | Annex IX with technical documentation assessment per generic device group | TD · CER · PMCF · PSUR (annual) |
| Class III | Annex IX with full technical documentation assessment, or Annex X with Annex XI | TD · CER · SSCP · PMCF · PSUR (annual) |
Standards our engineers and writers work with
We map each standard to the GSPRs it supports and to the evidence in your file, so reviewers can follow the trail from requirement to test report.
| Standard | Scope |
|---|---|
| ISO 13485:2016 | Quality management systems |
| ISO 14971:2019 | Risk management |
| IEC 62304 | Software lifecycle processes |
| IEC 62366-1 | Usability engineering |
| IEC 60601-1 | Basic safety and essential performance |
| ISO 10993 series | Biological evaluation |
| ISO 11135 · ISO 11137 | EO and radiation sterilisation |
| ISO 80369 series | Small-bore connectors |
| ISO 14155:2020 | Clinical investigation of devices |
| ISO 15223-1 · ISO 20417 | Symbols and information supplied |
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.