Technical Documentation and CE Marking
The essential foundation to demonstrate the safety, performance and compliance of medical devices and IVDs
The core of regulatory compliance
Technical documentation is the cornerstone of compliance for medical devices and in vitro diagnostics. It is the structured body of evidence that demonstrates a product’s safety, performance and quality in accordance with MDR 2017/745 and IVDR 2017/746.
CE marking is not a mere formality: it is the assurance that the device meets European requirements and can be used safely by patients and users.
MediQuasar supports organisations in drafting, reviewing and maintaining technical documentation, ensuring consistency, completeness and continuous updates throughout the device life cycle.
Audit-ready documentation for Notified Bodies and competent authorities.
What technical documentation includes under MDR/IVDR
Hazard identification, benefit–risk analysis and risk control measures in line with ISO 14971, integrated with post-market data.
A complete General Safety and Performance Requirements (GSPR) matrix linking requirements to testing, clinical evidence and harmonised standards.
Biocompatibility assessment of materials (ISO 10993), plans and reports, toxicological review and integration into risk management.
Clinical evaluation plan (CEP), clinical strategy, literature review, equivalence, benefit–risk analysis, CER drafting and ongoing updates.
PMS plans and reports, PSUR, PMCF, trending, and integration with CER and risk management.
The pathway to CE marking
CE marking attests that the device meets European requirements. MediQuasar supports every step of the process, ensuring documentary clarity, procedural accuracy and effective communication with Notified Bodies.
CE marking is not a mere formality: it is the assurance that the device meets European requirements and can be used safely by patients and users. MediQuasar supports organisations in drafting, reviewing and maintaining technical documentation, ensuring consistency, completeness and continuous updates throughout the device life cycle.
Step 1 →
Define the regulatory strategy
Step 2 →
Device classification
Step 3 →
Identify applicable standards and requirements
Step 4 →
Prepare technical documentation
Step 5 →
Engage with the Notified Body
Step 6
Post-market surveillance and ongoing updates
What MediQuasar provides
• Full drafting of technical documentation
• Review and updating of existing documentation
• Development and review of plans (CER, PER, BER, UER, PMS, PMCF)
• Support for laboratory testing and compliance verification
• Preparation for submission to the Notified Body
• Gap analysis and corrective roadmap
• Coordination with internal teams (R&D, Quality, Clinical)
• Alignment between risk management and CER
• Technical-regulatory audit preparation
• Ongoing post-market updates
Need support preparing your technical documentation?
We develop complete, consistent documentation that is ready for the Notified Body, reducing risk and approval timelines.
MediQuasar s.r.l.
Via Vittorio Veneto, 11,
41032 Cavezzo MO, Italia
Phone. +39 393 2859 8580
Mail info@mediquasar.it
Vat no. 04162970364