Technical Documentation Consulting
Comprehensive Medical Device Technical Documentation Services
Your product’s technical documentation is considered to be the cornerstone of EU regulatory compliance for medical devices and In Vitro Diagnostics (IVDs). Every medical device manufacturer placing devices on the EU market will need to put together and maintain technical documentation for each device, regardless of risk or classification.
The technical documentation required for medical devices and IVDs is indicated in Annexes II and III of the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic medical device Regulation (EU) 2017/746 (IVDR), respectively.
Navigating the intricacies of regulatory requirements can be challenging. That’s why we offer specialized services to build the essential technical documentation for your medical devices. Our experienced team understands the nuances of EU MDR and is dedicated to crafting precise and comprehensive technical documentation tailored to your unique product.
Consulting on all elements of the technical documentation is one of our core competencies. Throughout their time in the industry, the team has put together and reviewed hundreds of technical files for a wide range of medical devices and IVDs. Whether you are just getting started and struggling to understand EU requirements, or whether you are transitioning to meet the requirements of the new regulations, Specculo offers the services you need to comply with your obligations.
1. Technical Documentation Development
Our expert consultants specialize in creating meticulous Technical Files and Documentation, ensuring every aspect of your medical device is thoroughly documented. From design specifications to risk management and clinical evaluation, we cover it all.
We guide you through the process of compiling a robust Technical File, incorporating all necessary elements such as design and manufacturing information, risk assessment, and verification/validation data. Trust us to create a compelling narrative for your device’s compliance journey.
2. Risk Management Documentation
Risk management is paramount in medical device compliance. We assist you in developing thorough Risk Management Files, identifying, evaluating, and mitigating risks associated with your device, in line with EU MDR regulations and EN ISO 14971:2019 + A11:2021.
Our Risk Management File solution includes the Risk Management Plan, Risk Assessment, and Risk Management Report.
3. Clinical Evaluation Report (CER)
Our skilled team conducts in-depth clinical evaluations, gathering and analyzing data to create comprehensive Clinical Evaluation Reports. We ensure your CER meets the stringent requirements of EU MDR and state of the art guidance and best practice, substantiating the safety and efficacy of your medical device.
Our Clinical Evaluation Documentation include a Clinical Evaluation Plan, Literature Search Protocol, Literature Search Report, and the Clinical Evaluation Report.
4. Biological Evaluation Report (BER)
Navigating the complexities of biological evaluations is essential. We provide expert support in creating Biological Evaluation Reports, ensuring your medical device compies with EN ISO 10993-1:2020 and state of the art standards and guidance based on the contact type and duration of your product.
5. Post-Market Surveillance (PMS)
Effective Post-Market Surveillance (PMS) is essential for ongoing compliance. We offer comprehensive PMS solutions, including Periodic Safety Update Reports (PSUR) preparation and Post-Market Clinical Follow-up (PMCF) Plans in line with state of the art guidance. Our experts ensure your device’s safety and performance are continuously monitored, meeting EU MDR requirements seamlessly.
The process usually begins with a conference call to get an understanding of your medical device and any specifications you may have for the documentation. The first step will be to determine whether your product is a medical device or not, based on the definition within the MDR/IVDR. We may then request further information from you related to the device and begin to construct the technical file.
Depending on the complexity of the device, we may require further communication and may have additional questions to ask.
At the end of the project, you will be provided with complete technical documentation for your review. The file is then yours to keep and maintain, however, we remain at hand for any additions or amendments which may be needed. Furthermore, we provide consultation on how you can maintain the documentation yourselves throughout the product lifecycle.
Why Choose Us
- Experienced Consultants: Our team comprises seasoned regulatory professionals with a proven track record in EU MDR compliance.
- Customized Solutions: We tailor our services to match the specific needs of your medical device, ensuring accuracy and relevance.
- End-to-End Support: From initial assessment to document compilation, we offer comprehensive support throughout the process.
- Timely Delivery: We understand the importance of timelines in the regulatory landscape. Count on us for punctual and efficient service.
- Compliance Assurance: Rest easy knowing that your technical documentation is in line with EU MDR requirements, safeguarding your market access.
Embark on a smooth compliance journey with our expert technical documentation services. Contact us today to discuss your requirements and let us guide you toward EU MDR compliance success. Trust Specculo for meticulous, reliable, and expertly crafted medical device technical documentation.
Your Compliance Journey Starts Here – Contact Us Today!
What you get with Specculo
We have years of experience in handling large and small projects alike on a vast range of medical devices and IVD technology.