easyQ Solutions: Powering Medical Device Approvals Through Expert Clinical Evaluation

At easyQ Solutions, we simplify the complexity of Clinical Evaluation by offering support that is region-specific, expert-led, and compliant. We make sure your Medical Device complies with FDA, EU MDR, and other global regulations, from identifying data gaps to preparing audit-ready Clinical Evaluation Reports (CERs) enabling faster approvals and market success.

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Trusted by Medtech Leaders Globally

Our Services Include

easyQ Solutions support the entire lifecycle of Clinical Evaluation services to assist your Medical Device in navigating through complex regulatory landscape by customizing strategies for preparing the Clinical Evaluation Reports (CERs) and Clinical Evaluation Plans (CEPs) to meet the requirements of global health authorities such as FDA, EU MDR, and other global bodies.

Our Clinical Evaluation services offers:

Developing customized Clinical Evaluation strategies specific to various global markets by considering the regulations and standards set by health agencies such as FDA, EU MDR and other global bodies
Assistance in drafting Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER).
Providing Post Market Surveillance services to assure compliance following market entry, such as Post-market Surveillance Plans (PMSP) and Post-market Surveillance Report (PMSR)
Managing Post-market Clinical Follow-Up (PMCF) activities and developing Post-market Clinical Follow-Up Reports (PMCFR) to maintain compliance over time.
Coordinating with notified bodies and facilitating Medical Device panel meetings to ensure a smooth regulatory process and an efficient route to approval.

Why Our Experts for your Clinical Regulatory?

Clear Understanding of EU MDR & IVDR

We have strong knowledge of the European regulations for medical devices (MDR) and in-vitro diagnostics (IVDR).

Product-Focused Support

Our team takes time to understand your product first, and then helps you meet the regulatory requirements. We focus on what matters for your specific device.

Strong Knowledge of Clinical Data & State of the Art

We are experienced in working with clinical evidence, reviewing scientific literature, and establishing the state of the art as required under EU regulations.

On-Time Delivery

We understand the importance of timelines and ensure all deliverables are completed on schedule.

Experience with Key Regulatory Submissions

We have worked on multiple submissions including Clinical Evaluation Reports (CERs), Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF), and Periodic Safety Update Reports (PSURs).

Deep Regulatory Expertise

Our regulatory specialists have years of experience with global medical device regulations to understand the complexities of clinical evaluation and offer clear, actionable guidance for both new and existing products.

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Comprehensive Approach

We guarantee that every stage is in line with international standards by offering end-to-end support, from developing clinical evaluation strategies to post-market surveillance.

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Tailored Success

We customize our services according to your Medical Device unique requirements while taking the nuances of various regional regulations, such as the FDA, EU MDR and other global bodies.

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