Services
Focused EU MDR Writing Support
Specialised regulatory writing for clinical evaluation, post-market documentation, and Notified Body response work under EU MDR. We focus on what we do best so the quality of every document is consistent.
CER Writing & Remediation
For medical device teams that need a new, updated, or remediated Clinical Evaluation Report under EU MDR. We structure clinical evidence, state-of-the-art reviews, and benefit-risk conclusions in a way that is evidence-based and designed to support MDR review.
Suitable for Class IIa, IIb, III, and implantable devices.
What's included
- CER writing and structured updates
- Clinical Evaluation Plan support
- State-of-the-art literature narrative
- Clinical evidence summaries and appraisal
- Benefit-risk writing and conclusions
- Alignment with PMS, PMCF, risk, claims, and IFU
Notified Body Response Sprint
For teams that received Notified Body questions on clinical evaluation or post-market documentation. We review the comments, map the gaps, and produce structured, evidence-based responses and revised documentation.
We work to your response deadline. Contact us early for time-sensitive situations.
What's included
- Review and triage of Notified Body comments
- Response table writing
- Gap-based CER, PMS, or PMCF revisions
- Evidence-based justifications and rationale
- Consistency checks across affected documents
PMS, PMCF & PSUR Writing
For companies that need post-market documentation that connects back to the CER and benefit-risk conclusions. We write structured, audit-ready post-market documents that reflect the lifecycle evidence requirements of EU MDR.
Documentation structured to connect with your CER update cycle.
What's included
- PMS Plans and PMS Reports
- PMCF Plans with justified methodology
- PMCF Evaluation Reports
- PSUR writing and periodic updates
- Annual documentation update cycles
- Lifecycle evidence summaries for CER alignment
SSCP Writing Support
For Class III and implantable devices requiring a Summary of Safety and Clinical Performance. We write SSCP content that is clearly structured, aligned with clinical documentation, and appropriate for both healthcare professional and patient audiences.
Required under EU MDR for Class III and certain Class IIb implantable devices.
What's included
- Healthcare professional section writing
- Patient-facing summary (plain language)
- Clinical benefit-risk summaries
- CER and PMCF data alignment
- Plain-language review and consistency check
Related Document Review
Our EU MDR writing work often involves reviewing adjacent documentation for consistency — but our primary focus remains clinical evaluation and post-market writing.
- We review existing risk management documentation for consistency with CER benefit-risk conclusions.
- We check IFU and labelling claims against clinical evidence in the CER.
- We flag gaps in QMS documentation that may affect MDR technical file completeness.
- We do not position ourselves as QMS, FDA 510(k), IFU, or labelling writing specialists.
Not sure which service you need?
A Documentation Gap Review helps identify the right starting point before committing to full remediation.