MDR PMCF, PMS, PSUR & Vigilance

Post-market is an active evidence system, not an annual documentation exercise. We connect post-market clinical data to risk management, CAPA, CER and technical file maintenance.

Strengthen Your MDR Post-Market System

The Closed-Loop Lifecycle Feedback Model

Complaints & PMS Inputs

Signal & Trend Review

Risk Management Update

CAPA & Change Control

CER & PMCF Update

Technical File Update

12 Key Post-Market Compliance Deliverables

PMS Plan and PMS Report compilation (Class I devices)

PSUR strategy and preparation (Class IIa, IIb and III devices per Article 86)

PMCF Plan targeted specifically to residual clinical uncertainties

PMCF Evaluation Report authoring and integration with CER

Statistical trend reporting and safety signal evaluation

Serious incident and vigilance assessment under Article 87

Field Safety Corrective Action (FSCA) strategy, FSN and documentation

Complaint data evaluation and direct linkage to ISO 14971 risk files

CAPA linkage and corrective action effectiveness evaluation

CER update triggers and continuous clinical evidence maintenance

Summary of Safety & Clinical Performance (SSCP) annual updates

Periodic review of marketing claims and benefit-risk acceptability

Senior Regulatory View

Explain What New Clinical Knowledge Was Learned

A mature PMS system must clearly answer: What new clinical information was learned? Did the benefit-risk profile shift? Does the clinical evidence remain sufficient? And what updates were triggered in the technical documentation or labeling?

PSUR Submission Frequencies

Class III & Implantable: Annual update + EUDAMED upload

Class IIb: Annual update

Class IIa: At least every 2 years

Class I: PMS Report updated when necessary

PSUR / PMCF Support

Draft robust PSURs and PMCF evaluation reports to maintain CE mark validity.

Prepare PSUR Report

Maintain Seamless Post-Market Compliance Across the Device Lifecycle

Our post-market specialists establish closed-loop feedback systems that safeguard your CE mark certification.

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