Clinical and Post-Market Services
Demonstrate complete regulatory compliance by ensuring your Medical Device conforms to all applicable global requirements.
Navigating the complexities of clinical evaluation and compliance
Trust Apotech for expert clinical support
At Apotech, we offer comprehensive support to medical device manufacturers looking to navigate the complexities of clinical evaluation and regulatory compliance.
Our experienced team specialises in crafting meticulous clinical evaluation reports (CERs), developing robust clinical protocols and overseeing clinical trials tailored to meet the unique needs of each project.
Trusted by top-tier teams worldwide
Clinical Evaluation Plan (CEP)
Clinical evaluation plans for medical devices in the EU, UK other global markets are critical documents designed to ensure the safety and effectiveness of devices before they enter the market. These plans outline systematic approaches to gathering clinical data, assessing device performance and evaluating potential risks and benefits.
The EU MDR 2017/746 specifically emphasises taking a risk-based approach and requires comprehensive clinical evidence to support device safety and performance claims.
At Apotech, we can support you with your CEP in the following areas:
- Clinical evaluation summary and route
- Device description, state-of-the-art status and equivalence
- Risk management
- Literature search
- Data analysis and evaluation
Clinical Evaluation Report (CER)
The European Medical Device Regulation (MDR 2017/746) has significantly highlighted the importance of clinical data. Notified Bodies now require comprehensive clinical data that aligns with MEDDEV 2.7/1 rev 4 standards.
Manufacturers are required to have an up-to-date Clinical Evaluation Report (CER) as part of their technical documentation in both the UK – to obtain a UKCA mark – and the EU – to obtain a CE mark.
A CER for medical devices is a comprehensive document that systematically assesses and analyses clinical data related to the safety, performance and effectiveness of a medical device. Its purpose is to demonstrate the device's conformity to essential requirements and applicable regulations, ensuring its safety and efficacy for patient use.
Our team can support you with your CER in the following areas:
- Clinical scope, context and state-of-the-art status
- Device description developmental context
- Risk management
- Clinical evaluation methodology
- Literature search
- Analysis of performance and safety
Post Market Surveillance (PMS)
Under the EU MDR, Post Market Surveillance (PMS) encompasses various activities that are aimed at monitoring and evaluating the safety and performance of medical devices once they are placed on the market.
Every manufacturer is required to plan, establish, document, implement, maintain and update a PMS system for every medical device.
At Apotech, we can support you with your PMS in the following areas:
- Post Market Clinical Follow-Up (PMCF) plan and report
- Vigilance systems
- Periodic Safety Update Reports (PSURs)
- PMS plan and report
- Complaint handling
- Adverse event handling and reporting
- Risk management
- Field Safety Corrective Actions (FSCAs)
Post-Market Clinical Follow-Up (PMCF)
The EU MDR also requires manufacturers to conduct a clinical evaluation that includes a Post Market Clinical Follow-up (PMCF).
This is a regulatory requirement that mandates manufacturers to systematically gather and evaluate clinical data on products after they are placed on the market. It aims to continuously monitor the safety and performance of your medical devices in real-world clinical settings and complement pre-market evaluations.
Our team can support you with:
- PMCF plan development
- Literature review and analysis
- Protocol development
- Statistical analysis plan
- Study report
Clinical Trial Consulting
Conducted by Apotech Team of Clinical Experts with 20+ years' experience in trials and compliance, Apotech offers tailored clinical study design and protocol development services, carefully balancing the needs of various stakeholders. Our experienced clinical trial research consultants provide expert guidance on essential elements of study design, considering the necessity, implications, and practicality of each decision. This collaborative approach optimizes trial protocols, addressing all stakeholder perspectives effectively. Apotech can support you in the following areas:
- Study Design
- Draft FDA IDE submission, including Protocol Summary
- Health Economics & Reimbursement Planning
- Literature Review
- Participation in Pre-IDE Interactions with FDA
- Protocol Writing & Review
- Resource Planning
- Statistical Analysis Plans for Clinical Trial Protocols
- Submission of IDE to FDA
- Clinical Investigation Plan
- Investigator's Brochure
Why choose Apotech for MedTech clinical and post-market services?
From conducting thorough literature reviews to designing clinical studies and analysing data, our team ensure that our clients receive expert guidance and support at every stage of the process.
Whether you're navigating the requirements of the EU MDR, FDA regulations or other global standards, our consultancy provides strategic insights and hands-on assistance to help you achieve regulatory approval and commercial success for your medical devices.
Featured case studies
Software as a medical device (SaMD)
Software as a medical device (SaMD) Introduction Our client designs and sells a CE marked Class IIa software, used in cardiology as a digital twin. Types Regulatory affairs Responsible person FSP Scope of work Our client recently partnered with groups of clinics in the United Kingdom and therefore asked us to act as their UK…
QMS Implementation for Class III Medical Device
QMS Implementation for Class III Medical Device Introduction Streamlining ISO 13485 Certification for a connected medical device. The company is a highly innovative start up, which has developed a best-in-class pacemaker. At the time of engaging with them they were on the road to CE Marking. Apotech Team Worked full time on the project: balanced…
Borderline device classification
Borderline device Classification Introduction Classification of borderline product (cosmetics VS medical device) Our client, a multinational cosmetics and wellness product manufacturer identified revenue opportunities marketing their cosmetics devices with increase claims. Apotech was engaged to perform a blanket regulatory assessment of cosmetic devices and provide judgement and pathways for market authorisation as a medical device…
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