“Medical writing and translation – human expertise offers more than artificial intelligence!”
As a medical manufacturer, you are obliged to comply with many national and international legal requirements – a task that requires a careful and analytical approach, especially in the area of documentation. I support you in meeting all regulatory requirements and delivering on time – and therefore promoting the success of your products right from the start! Ich unterstütze Sie dabei, alle regulatorischen Vorgaben zu erfüllen und termingetreu zu liefern – und somit den Erfolg Ihrer Produkte von Anfang an zu fördern!
Preparation and translation of clinical evaluations of medical devices
Preparation of clinical evaluations of medical products in risk class 2b/3
I prepare audit-proof and regulatory-compliant assessments taking into account the latest developments in the risk-benefit assessment of medical devices.
All assignments are carried out in both English and German.
Compliance with the current requirements of the EU Medical Device Regulation (MDR) and other national and international regulations
In order to place medical devices on the market in the EU, compliance with the EU Medical Device Regulation is mandatory. I can provide you with comprehensive support in this regard, including the translation of all documents.
Cooperation partner
Nick Watson, a native British English speaker and highly experienced translator, has successfully managed his agency, Watson Translations, based in Ludwigshafen am Rhein, for over 25 years. Specializing in translation and interpreting services for technical, legal, financial, and marketing texts, he brings a strong linguistic background and in-depth expertise in the fields of translation and customer service.
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About AB-Evaluation
Nationally and internationally, medical manufacturers are subject to a high level of legal requirements and documentation obligations. With my 20 years of professional experience in the organization and documentation of clinical trials and my 30 years of professional experience as a medical and legal translator and interpreter, I offer you exactly the support you need as a medical device manufacturer.
My high level of expertise in both areas as well as my careful and analytical way of working will help you to meet all regulatory requirements and deliver on time. Together we can ensure the success of your products right from the start!
In the medical field in particular, a high level of specialist knowledge is essential in order to produce translations that are accurate and meaningful. A normal translation agency or artificial intelligence cannot achieve this. With my experience in the scientific, medical and documentary fields as well as in the translation of medical and legal texts, I combine all relevant fields and can therefore provide you with ideal support.
The highest security standards and fully digitized work are a matter of course for me. One area here is the use of electronic legal transactions (ERV). This enables fast and secure communication with the courts. Postal transmissions are now a thing of the past.
Qualifications & Professional Experience
- Graduate Translator/Interpreter German – English – German (University of California)
- Scientific document specialist (Institut für Information und Dokumentation der FH Potsdam)
- Consultant for clinical studies (Pharmaakademie Nürnberg)
- Medical document specialist (Universitätsklinik Tübingen, Paul-Ehrlich-Institut)
- Sworn negotiation-interpreter and publicly appointed and sworn document translator for English (Landgericht Stuttgart, Geschäfts-Nr. 316-II/5/1969)
- Quality Auditor/Quality Officer (DIN EN ISO 9001:2015)
- Occupational health and safety management auditor (TÜV Rheinland Qualifikation)
- 30 years of professional experience as a medical and legal translator
- 20 years of professional experience in the organization and documentation of
of clinical trials - Conducting feasibility studies in several countries
- Preparation of marketing authorization applications for authorities and commissions
Many years of experience in the field of clinical studies
Comprehensive knowledge through continuous further training and certification measures
Audit readiness in accordance with all current DIN and ISO standards
Accuracy of fit (advantage over artificial intelligence-based work)
Extreme care in the preparation and translation of clinical evaluations of medical devices
Customized for the international market
Fully digitalized office and use of electronic legal transactions (ERV)
Contact
Annette Burkhardt
Phone: +49 (0) 176 34 74 94 85
E-Mail: info@ab-evaluation.de
SAFE ID for electronic legal transactions (address book of the judiciary):
DE.Justiz.ef017735-4908-4b03-9934-76b522c6431c.8357