Our Services

Strategy

Our highly qualified experts can build you a dedicated pre-clinical, clinical, and regulatory strategy ensuring cost-effectiveness with high-quality data.

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Your clinical strategy, which data you generate and collect and how you report your results can support your device's regulatory claims and requirements. 

 

By establishing early and clear definitions of the target population, clinical benefits, and outcome parameters, you ensure coherent parameters and a focused plan for an excellent study design, clinical data generation, and clinical evaluation report. 
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We can support you right from the beginning in developing coherent design, risk, regulatory, and final clinical aspects of your device for an advanced submission package.
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We can also step in at any stage to review and enhance your regulatory and clinical strategic planning and execution for market clearance.​

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Alignment

Top-quality regulatory submission packages require all related departments of the device development process to be aligned and coherent. 
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We can ensure that your design input, R&D activities, device mode of action, risk management, clinical studies, and clinical evaluation are perfectly aligned.

​Multidisciplinary communication between your departments lowers the chances of inconsistencies, prevents you from performing unnecessary studies, and facilitates gap analysis for an easier and faster submission process.

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Compliance

We promote your medical device submission package in a realistic, hands-on, and practical approach, with an understanding of the regulatory requirements and your company's capabilities. 

 

We have expertise in both pre- and post-market requirements.

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Peer Review

Our medical experts include team members with both FDA and EC experience. Some team members have experience as NB medical reviewers.

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Our experts can perform a pre-submission review of your regulatory and clinical documents before your submission to enhance submission qualification for faster approval.

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Liaising

We can provide you with strategic regulatory liaising between your company and your NB/regulator at any stage of your product development. This includes communication support and problem solving following requests and non-conformities.

Clinical Investigation

- Building clinical development plan

- Study design to be complaint with regulatory strategy (EU, 

   FDA, SA other) and to support clinical claims

- Support with regulatory submission (FDA, EMA, MHRA,

  TGA, Israeli MoH, SA and other)

- Senior CRA with experience with eTMF manager, patient

   recruitment, monitoring, budgets reviewer

- CRO oversight specialist

- FDA inspection prep

- Regulatory audit prep

- EC & IRB assessment prep

 

Data management

- Design and setup of data management solutions

- Database design and documentation

- Data acquisition setup

- Data transfers for eCRF and clinical database systems

- Data cleaning

- Data visualization and analysis

 

Biostatistics

​- Study protocol overview and description of safety and

   efficacy endpoints.

- Sample size and power calculations

- Preparing statistical analysis plan (SAP) including statistical

   methods writing for safety, tolerability and efficacy

   measurements.

- Creation of final statistical report with findings.

Clinical Evaluation (CEP & CER)

Compliance with the MDR requires a comprehensive clinical evaluation process and the writing of the clinical evaluation report (CER).

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Our team of MDs and PhDs, including MDR qualified medical reviewers, provides support with clinical evaluation and/or clinical performance process to meet MDR requirements. 

 

Our team can help with developing and reviewing clinical evaluation or writing the plans and reports (CEP and CER). Our team  will verify that the clinical strategy presented in the clinical evaluation is in alignment with the rest of the technical documentation. 

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The CER is essential for determining the safety and performance of a medical device and assessing it’s risk and benefits.

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1. Clinical data: The clinical evaluation process must be based on relevant clinical data, including clinical investigations, published literature, and post-market surveillance data. The data should be gathered from a range of sources and analyzed in a systematic and transparent manner.

2. State of the art: The clinical evaluation process should consider the current state of the art in medical practice and the latest developments in technology and medical science. This is particularly important when assessing the safety and performance of novel medical devices.

3. Risk assessment: The clinical evaluation process should include a comprehensive risk assessment that considers the potential risks associated with the use of the device and the likelihood of harm occurring. The risk assessment should be based on both clinical data and expert opinion.

4. Writing the clinical evaluation report: The CER should provide a clear and concise summary of the clinical evaluation process, including the data sources used, the methods employed, and the conclusions drawn. The report should also include a discussion of any residual risks and the measures taken to mitigate them.

5. Expertise: The clinical evaluation process and the writing of the CER should be carried out by qualified personnel with relevant expertise in clinical research, medical device development, and regulatory affairs.

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Overall, compliance with the MDR requires a rigorous and systematic approach to clinical evaluation and the preparation of the CER. This ensures that medical devices are safe and effective and meet the highest standards of patient care.

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Clinical Performance (CPP & CPR)

For compliance with the In Vitro Diagnostic Regulation (IVDR), a comprehensive clinical performance process and the writing of a clinical performance report (CPR) is essential. Our team of MDs and PhDs, can provide support with clinical performance  process  to meet IVDR requirements. 

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Medtech SMEs can help with developing, reviewing clinical  performance or writing the  plans and reports (CPP and CPR). Our team will verify that the clinical strategy presented in the clinical evaluation is in alignment with the rest of the technical documentation. 

 

Here are some crucial aspects that need to be considered for compliance with the IVDR:

1. Clinical performance data: The clinical performance process must be based on relevant clinical performance data generated from clinical performance studies, performance evaluation reports, post-market surveillance data, and other relevant sources.

2. Performance evaluation: The clinical performance process should include a comprehensive performance evaluation that considers the device's intended use, target population, and performance characteristics.

3. Analytical and clinical performance: The clinical performance process should evaluate both the analytical and clinical performance of the device. The analytical performance assesses the technical aspects of the device's operation, while the clinical performance evaluates the device's performance in a clinical setting.

4. Risk assessment: The clinical performance process should include a comprehensive risk assessment that considers the potential risks associated with the use of the device and the likelihood of harm occurring. The risk assessment should be based on both clinical data and expert opinion.

5. Writing the clinical performance report: The CPR should provide a clear and concise summary of the clinical performance process, including the data sources used, the methods employed, and the conclusions drawn. The report should also include a discussion of any residual risks and the measures taken to mitigate them.

6. Expertise: The clinical performance process and the writing of the CPR should be carried out by qualified personnel with relevant expertise in clinical research, in vitro diagnostic development, and regulatory affairs.

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Overall, compliance with the IVDR requires a rigorous and systematic approach to clinical performance evaluation and the preparation of the CPR. This ensures that in vitro diagnostic devices are safe and effective and meet the highest standards of patient care.

Comprehensive Post-Market Surveillance (PMS) services

We provide tailored solutions to ensure compliance and safety. Our PMS services include the collection, analysis, and interpretation of post-market data, such as adverse events, complaints, and feedback, to proactively identify and address potential issues.

 

We also assist with developing and implementing PMS plans, generating reports for regulatory submissions, and providing strategic recommendations for continuous improvement.

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Post-Market Clinical Follow-up (PMCF)

PMCF is a crucial step in ensuring the safety and performance of medical devices and in vitro diagnostics after they have been placed on the market.

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Our team can help with the development of PMCF plans, conducting PMCF studies, analyzing and reporting the results, and supporting your company in meeting regulatory requirements.

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Trend Analysis

Trend analysis is a critical component of post-market surveillance. We can help you set up the data collection and statisitcal analysis needed to comply with the trend analysis requirements of the MDR or IVDR for your device and create QMS documents describing the process.

Audits

Our team of SMEs specializing in the MedTech industry offer third-party audit and due diligence services to help companies manage risk and ensure compliance with regulatory requirements.

 

Our team of subject matter experts provide objective assessments of a company's quality management systems, manufacturing processes, and product development practices. MedTech SMEs team also assess a company's supply chain and evaluate suppliers' quality management systems to ensure that they meet industry standards.

 

Through these services, our expert consultants help companies identify potential areas of risk and provide recommendations for improvement to mitigate those risks.

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Due Diligence

We can also provide due diligence services to support companies in evaluating potential acquisitions or partnerships, helping them to assess the quality and compliance of target companies.

Medical Writing

Professional medical writing requires years of experience and knowledge. Our team of experts provides both.

 

We can offer you the following services:

- Publication strategy development

- Journal selection

- Preparing papers for publication in scientific journals

- Assistance with journal submission and peer review

- Writing and editing of grants, research proposals, SOPs,

   abstracts

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Literature Reviews

Literature reviews are crucial in many steps throughout a medical device development process, such as designing a new study, preparing a clinical evaluation report, or performing risk management procedures.​ A professional literature review that includes a protocol and the right keywords help you get it right the first time and improve your expertise in your field.

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Our literature review process ensures compliance and traceability. The searches, data extraction and analyses are set up to be easily updated throughout the life cycle of your device.

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Medical Communication

Communicating with your doctors, patients, or company stake holders may require different approaches and styles. We can assist you with all target audiences.

 

We can provide content and design for:

- Brochures

- Websites

- Newsletters

- One- and two- pagers

- Posters

- Case studies

- Presentations

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These may serve you to build medical training, patient information, scientific and marketing material, all of which are important tools that help you achieve your goals and increase the value of your product and company.

Training

Keeping abreast of regulatory requirements and ensuring your company's processes are compliant can seem a daunting task. We can provide the training and guidance you need to implement a compliant regulatory roadmap with confidence.

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Popular training topics include clinical evaluation requirements under the MDR, systematic literature reviews and PMS trend analysis.  Custom trainings are possible on request. 

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Mentoring

While providing services, we train your team during the process. With this training, the know-how stays in the company for future projects and/or yearly updates.

 

Certificates

Certificates are delivered following training.