We make it simple!
Multi-Year Excellence
We have been working in the medical device industry for more than 20 years, gaining cross-functional experience covering design activities, control and optimization of manufacturing processes, regulatory compliance, implementation of quality management systems, and design and implementation of post-marketing activities such as clinical investigations and clinical follow-up studies.
Services for Medical Devices and IVDs.
To address MDR, IVDR and clinical requirements without regulatory uncertainty.
We support medical device and IVD companies throughout the regulatory and clinical lifecycle.
Clinical Surveys
Design and execution of clinical investigations, processing of statistical analysis, report of the investigation, clinical evaluation and re-planning data collection.
Medical Writing
Developing and writing scientific texts for clear, quality communication that provides value.
Extra-EU Countries.
Support in DM and IVD registration activities in Extra-EU countries for marketing.
Regulatory Affairs
To achieve and maintain compliance with Regulation (EU) 2017/745 and (EU) 2017/746
Audits
Internal audit services, qualifying suppliers, distributors, importers and agents to ensure compliance with industry standards.
Training
Customized training for individuals and company on quality management, regulations, supplier qualifications, risk management.
Why choose FTR Advisor?
- Experience on MDR, IVDR, clinical evidence, and software as a medical device
- Integrated approach: regulatory, clinical, and quality across the lifecycle
- Constant alignment to regulation, guidelines, ISO standards and practices
- Focus on regulatory risk reduction and rework
How do we work?
We adopt a now validated model that is based on:
- Listening to the needs of each party involved
- Case study and client vision
- Analysis of strengths and weaknesses
- Tailored strategy development
Regulatory Compliance (MDR and IVDR)
Clinical Strategy - Pre- and Post-Market Data
Quality management systems and outsourcing
Software and AI
Global Market Access Decision
Clinical and Clinical Performance Evaluation (CEP/CER - PEP/PER)
Biological Evaluation (BEP/BER)
Audit
Training
Contact us for any consulting, training or simply to ask a question.
We will be happy to answer your doubts or requests. We will be your support to eliminate doubts in the complex regulation of quality management systems or regulatory affairs or solve specific problems.