Mediteq has experience in demanding and complex areas, and can help you to move forward in the work of risk management, clinical data, biological evaluation, and safety monitoring.
Risk management
Do you need more energy and structure in your risk work?
Is risk management theoretical and abstract to you? Is it difficult for the risk team to see the completeness and end of the risk management work? Mediteq can help to create structure and plans for the risk management work including facilitating risk analysis sessions, writing complete documentation and conclusions together with the risk team.
We offer a service that can take you from understanding the requirements
to a complete risk management file according to ISO 14971.
- Training and materials
- Limitations
- Tools and process implementation
- Risk analysis in iterations
- Report and conclusions
Risk management work is cross-functional team work and it is important that there are available resources in your organization. Mediteq can help you do the job – but your organization have the knowledge and information about the product and its use. After implementation, you will have a definded risk process with associated risk documentation for your product, as well as knowledge to continue forward on your own or with Mediteq.
After completion, you will have an initiated and documented risk analysis with accompanying risk documentation, as well as solid knowledge to continue moving forward.
Clinical evaluation
Feeling lost when someone mentions “clinical evaluation”? You’re not alone. This uncertainty is common.
Many teams assume it is just another document to complete at the end of the process — or hope they can avoid it entirely.
But here’s the truth: a clinical evaluation isn’t a bureaucratic hurdle. It’s one of the most powerful strategic tools you have!
A well‑constructed clinical evaluation provides essential insights into the medical landscape surrounding your device, compare your device with existing solutions (benchmark), identify evidence gaps, and determine exactly what is needed to demonstrate the performance and safety of your product.
In practice, the clinical evaluation shapes your clinical strategy and defines the most appropriate clinical pathway for your device.
Ultimately, it strengthens your regulatory position and increases the likelihood of successful market access.
If you’re unfamiliar with the process or unsure where to begin, Mediteq turns complexity into a clear, structured, and efficient process. We offer a range of solutions — from full development and writing of your clinical evaluation to targeted, device‑specific support services, including:
Full clinical evaluation writing:
Mediteq can manage the complete development and writing of your Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER).
Timelines are adapted to your device’s complexity (intended use, classification, benefits, claims, etc.), maturity of your existing technical documentation (risk management, PMS, etc.), and phase of your product development (early phase, pre–design freeze, or pre‑submission).
Guidance and support:
If you prefer to write the clinical evaluation yourself, Mediteq’ provides targeted support.
You will receive our MDR-compliant template, and the service includes three 2‑hour guidance sessions where we walk you through the key steps of your clinical evaluation.
Additional support or document review can be provided as needed.
Independent review of your clinical evaluation:
Mediteq offers comprehensive, independent reviews of your CEP, CER, or both.
We identify common issues, evidence gaps, and areas requiring improvement—helping you avoid delays and non‑conformities during regulatory assessment.
Support when responding to notified bodies:
If your notified body raises questions or identifies non-conformities, Mediteq can help you prepare clear, well‑reasoned, and compliant responses.
We guide you in addressing deficiencies efficiently and effectively.
Writing or updating the state of the art (SOTA):
State of the Art reports differ significantly from conventional scientific reviews.
Mediteq can support the development of your initial SOTA to ensure alignment with MDR expectations.
We also update literature searches or prepare focused reviews (e.g., indication expansion, specific sub‑groups)..
Other Medical Writing Services:
Mediteq also provides a range of complementary services, including:
- justification of population similarity (commonly required for FDA submissions)
- identification of relevant clinical endpoints for investigations or PMCF study
- targeted literature reviews for R&D, exploratory work, or product scope expansion
- support with adjacent processes, such as risk management or post‑market surveillance
Biological evaluation
During development and use of a medical device, it is important to keep track of biocompatibility data. Knowledge about different materials are continously gained. With a risk based approach, Mediteq can assist in planning, analysing, and writing the report for biological evaluation according to today’s regulatory requirements.
Safety monitoring
Does post‑market surveillance (PMS) and post-market clinical follow-up (PMCF) feel vague, abstract, or downright overwhelming? You are not alone. PMS is one of the most challenging areas of the MDR — and also one of the most misunderstood.
Many manufacturers struggle to interpret what the regulation truly expects, how much data is “enough,” or how to translate real‑world performance into
meaningful documentation. But PMS doesn’t have to be intimidating.
When handled correctly, it becomes one of your most valuable assets: a way to understand how your devices perform in real life, anticipate issues before they arise, and strengthen your overall regulatory strategy.
Mediteq helps you turn complex PMS requirements into a practical, understandable, and compliant system, whether you need help with a single task or wish to outsource the entire process.
We help you transform PMS and PMCF from a regulatory burden into a powerful source of insight.
To support you in meeting PMS and PMCF requirements, Mediteq offers extensive experience across all aspects of these activities.
Post-market surveillance (PMS) activities
Effective post‑market surveillance is essential for identifying potential safety issues, meeting regulatory obligations, and maintaining the trust of users and authorities. Mediteq can support you with:
- Development and refinement of PMS processes
- Preparation of PMS Plan, PMS Report, and PSUR
- Corrective and Preventive Actions (CAPA)
- Reporting, investigating, and documenting serious incidents and field safety actions
- Support in responding to Notified Body comments or non‑conformities
Post-market clinical follow-up (PMCF) activities
Manufacturers are required to continuously and proactively collect real‑world clinical evidence to confirm device performance and safety. Mediteq can assist with:
- Integrating PMCF outputs into Risk Management and technical documentation
- Writing/ updating your PMCF Plan
- Designing and conducting PMCF studies
- Surveys, user feedback, registry strategy, and real‑world data collection
- Conducting literature updates, vigilance database searches, and alignment with the clinical evaluation