A Clinical Evaluation Report (CER) is a mandatory document required under the EU MDR that evaluates all available non-clinical and clinical data—scientific literature, clinical trials, post-market data, risk management data and equivalent device information—to prove the safety and performance of a medical device.
PM Consultants prepares fully compliant CERs by analyzing clinical evidence, identifying data gaps, evaluating risk-benefit, and aligning documentation with EU MDR Annex XIV requirements. This ensures your device remains market-ready and compliant during audits and CE Marking submissions.
Our clinical evaluation report writing service includes:
This service ensures your device meets EU MDR and regulatory reviewer expectations.
PM Consultants prepares both CEP & CER in alignment with EU MDR Annex XIV, ensuring consistency, completeness, and regulatory acceptance.
A Risk Management Plan outlines the approach for identifying, evaluating, controlling, and monitoring risks throughout the device lifecycle.
It typically includes:
Our team develops risk management plans compliant with ISO 14971:2019.
Risk management is a structured process (as per ISO 14971) to ensure that medical devices remain safe and effective.
It includes hazard identification, patient risk assessment, probability estimation, and implementation of control measures.
Regulators in both the EU and USA require manufacturers to maintain a complete risk management file for device approval.
Post-Market Surveillance refers to the continuous monitoring of a device after it has been placed on the market.
PMS ensures:
PM Consultants prepares PMS reports, PSURs, PMCF surveys, and trend analyses to meet EU MDR and FDA expectations.
Our PMS report writing covers:
These deliverables support regulatory reviews, audit readiness, and ongoing device safety monitoring.
Medical device regulations are complex and vary between markets.
Regulatory consulting helps manufacturers:
PM Consultants offers full-spectrum of regulatory affairs consulting services for medical devices to simplify the approval process and ensure global compliance.
A Technical File/Design Dossier includes all documentation required to demonstrate the conformity of a medical device.
It typically covers:
Our team prepares complete and audit-ready technical files aligned with EU MDR Annex II and III.
Quality System Documentation ensures that a manufacturer follows a structured and controlled process for device development, manufacturing, and post-market activities.
This includes:
PM Consultants helps create and implement QMS documentation compliant with ISO 13485.
Yes. Our medical writing for regulatory submissions includes:
All documents follow global regulatory standards and are written by experienced medical and regulatory writers.
Yes. Our medical writing for regulatory submissions includes:
All documents follow global regulatory standards and are written by experienced medical and regulatory writers.
Our consulting services support:
We help clients at every development stage—from concept to post-market compliance.
We support manufacturers by:
This reduces development delays and streamlines market approval.
Update frequency depends on device risk class and regulatory requirements:
PM Consultants provides complete lifecycle documentation support.
At PM Consultants we are a group of dedicated medical writers, regulatory affairs professionals, clinical researchers, and quality
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