The AKRN Medical Writing Services develop the documentation that regulatory agencies require in the approval process for medical devices. These regulatory documents require a strong scientific and technical expertise in order to summarize the necessary data collected in the course of developing a medical device product.
A CE Marking Technical File or Design Dossier (Class III) is a comprehensive description of your device intended to demonstrate compliance with European requirements. Compiling your technical file or design dossier is a critical step in Europe’s CE Marking Process and a requirement for compliance with the Medical Devices Directive 93/42/EEC and the new Medical Devices Regulation MDR 2017/745.
Your technical file or dossier includes detailed information about the design, function, composition, use, claims, and clinical evaluation of your medical device. They are required for all classes of devices (Class I, IIa, IIb and III) but no two technical files are the same because the type of device dictates the information included therein. Your Technical File must be reviewed by a Notified Body (unless you manufacture a Class I device) that is not provided sterile and does not have a measuring function. Understanding how to assemble this information and present it for review by Notified Bodies is essential. We can support you in this process by:
- Reviewing all existing documentation in support of meeting the applicable Essential Requirements / GSPRs
- Evaluate and identify gaps or deficiencies in your documentation.
- Compile your EU Technical File or Design Dossier, with internal peer review.
- Determine applicable testing requirements and standards for your device.
- Review your clinical data, compile a Clinical Evaluation Report (CER), and facilitate a Risk Assessment as necessary.
- Review your proposed labeling and Instructions for Use.
AKRN can provide state-of-the-art literature researches on emerging technologies, MedTech innovations, and medical trends which can provide background summaries, reports, and manuscripts in the medical and scientific setting.
AKRN works with manufacturers preparing the following key reports.
- Clinical Investigational Plan (CIP) according to ISO14155:2019 and MDR 2017/745
- Clinical Study Reports (CSR)
- Clinical Literature Research and Reports according to MEDDEV 2.7/1 Rev 4
- Clinical Evaluation Reports (CER) according to MEDDEV 2.7/1 Rev 4
- Summary of Safety and Clinical Performance (SSCP) according to MDR 2017/745
- Post Market Surveillance (PMS) Plans
- Post Market Clinical Follow Up (PMCF) Protocols
- Investigator Brochure (IB) Development
A key task of the Medical Writing service is to be sure that all deliverables are in accordance with regulations, standards, and guidelines. The regulatory documents that the AKRN Medical Writing team prepare meet ISO 14155 and GCPs guidelines, MEDDEV 2.7/1 Rev 4 and MDR 2017/745. Our team have a comprehensive understanding of the level of evidence required to achieve regulatory demands.