Dr. Susanne Merk
Need safe navigation towards audit ready clinical evaluation?
When your medical device clinical evaluation project demands precision, regulatory confidence, and experience, this is what I bring to the table:
20 years+ of experience supporting class I-III medical devices
PHD in Biology (TU Munich; University of Würzburg)
Statistics training (Duke University)
Regulatory Affairs Medical Devices Training (University of Lübeck)
How I can help
Consultation: Clinical strategy planning
Process implementation: Clinical Evaluation MDR, RM ISO 14971, PMS MDR
Document creation: CEP / CER / SotA / SSCP / PMCF Plan and Report as well as CIP / CIR (CSP / CSR) ISO 14155
Project Experience
>50 clinical evaluations (MDD/MDR) for more than 20 product groups
Clinical strategies for medical devices including clinical trials (ISO 14155)
Process implementation for Risk Management, PMS and Clinical Evaluation
Scientific medical publications
Reimbursement applications for drug like medical devices in Germany (G-BA)
Scientific medical publications
Systematic literature reviews
References upon request
Contact me for a free intro call
Imprint
Dr. Susanne Merk
Kosthofstr. 35b
82205 Gilching
Germany
Fon: +49-1773718190
Mail: info(at)susanne-merk.de
VAT ID: DE 288 512 954
General Terms and Conditions
of Dr. Susanne Merk Medical Writing, Kosthofstr. 35b, 82205 Gilching, Germany
Telephone: +49 8105 730 1 730,
E-mail: [email protected]– hereinafter referred to as the “Contractor” or “we” –§ 1 Scope of Application, Form(1) These General Terms and Conditions (GTC) apply to all business relationships with our customers. The GTC apply only if the customer is an entrepreneur within the meaning of § 14 of the German Civil Code (BGB), a legal entity under public law, or a special fund under public law.(2) Unless otherwise agreed, these GTC in the version valid at the time of the customer’s order, or in any case in the version last communicated to the customer, shall also apply as a framework agreement for similar future contracts without the need for renewed reference in each individual case.(3) These GTC apply exclusively. Deviating, conflicting, or supplementary general terms and conditions of the customer shall only become part of the contract if and insofar as we have expressly agreed to their validity. This applies in all cases, even if we perform services with knowledge of the customer’s terms without reservation.(4) Individual agreements concluded with the customer in individual cases (including ancillary agreements, supplements, and amendments) shall in all cases take precedence over these GTC. Subject to proof to the contrary, the content of such agreements shall be governed by a written contract or our written confirmation.(5) Legally relevant declarations and notifications by the customer relating to the contract (e.g. setting deadlines, notices of defects) must be made in writing, i.e. in written or text form (e.g. letter, e-mail, fax). Mandatory statutory form requirements remain unaffected.(6) References to statutory provisions are for clarification purposes only. Statutory provisions shall apply even without such clarification unless they are expressly amended or excluded in these GTC.§ 2 Offer and Conclusion of Contract(1) Offers and price information contained in brochures, advertisements, and other promotional materials are subject to change and non-binding.(2) We are bound by our offers for fourteen (14) calendar days after dispatch. The customer may accept the offer within this period. Timely acceptance shall be determined by receipt of the acceptance by us.§ 3 Customer’s Obligations to Cooperate(1) The customer shall provide the contractor with all data, product information, and materials required for performance of the services and shall treat such materials as strictly confidential.(2) Where the customer provides materials or information for use in the preparation of texts, the customer warrants that it is entitled to provide and use such materials.(3) Acceptance of a draft proposed by the contractor shall constitute approval. Subsequent changes generally require additional technical and organizational effort.
Change requests submitted after approval shall result in an adjustment of the existing contract. The contractor is entitled to charge any resulting additional costs and adjust delivery deadlines accordingly. The customer shall be informed in advance of the anticipated additional costs and schedule implications. The contractor may reject change requests if they are unreasonable.(4) The customer alone is responsible for compliance with statutory provisions, in particular those relating to medical device law, pharmaceutical law, and healthcare advertising law.§ 4 Delivery Period and Delay(1) Delivery periods shall be agreed individually or specified by us upon acceptance of the order.(2) If binding delivery deadlines cannot be met for reasons beyond our control, we shall inform the customer without delay and communicate a revised delivery period. If performance is also unavailable within the revised period, we may withdraw from the contract in whole or in part and shall refund any consideration already received without delay.(3) Delay shall be governed by statutory provisions. In all cases, a reminder from the customer is required.§ 5 Prices and Payment Terms(1) Prices are exclusive of statutory value-added tax and any shipping costs. Customs duties, expenses, and similar charges shall be borne by the customer.(2) Where invoicing is agreed, invoices are payable within ten (10) working days of delivery and receipt of the invoice, unless otherwise agreed.(3) Rights of set-off or retention shall exist only insofar as the customer’s claim has been legally established or is undisputed. Customer rights in the event of defects remain unaffected.(4) If, after conclusion of the contract, it becomes apparent (e.g. through the filing of insolvency proceedings) that our claim to remuneration is jeopardized due to the customer’s lack of ability to perform, we may refuse performance and, where applicable after setting a deadline, withdraw from the contract in accordance with § 321 BGB.§ 6 Special Provisions for Scientific Publications(1) Dr. Susanne Merk works in accordance with the guidelines of the European Medical Writers Association (EMWA). Where a professional medical writer is involved in scientific manuscripts or congress contributions, it must be ensured that:the writer has access to all relevant information (e.g. protocols, statistical analysis plans, analyses, study reports);intellectual input is provided before and during manuscript development;the final text reflects the views of all authors and is approved by all authors;the appropriateness of the chosen journal or conference is confirmed;the involvement and nature of support by a professional medical writer is disclosed;co-authorship is recognized in accordance with the four ICMJE criteria:substantial contributions to conception, design, data acquisition, analysis, or interpretation; ANDdrafting or critical revision of the work; ANDfinal approval of the version to be published; ANDaccountability for accuracy and integrity of the work.(2) The following acknowledgement text shall be used in accordance with the Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals:“The authors thank Susanne Merk for providing medical writing support/editorial support [specify and/or expand as appropriate], which was funded by [sponsor, city, country] in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).”§ 7 Liability(1) Unless otherwise stated, we are liable in accordance with statutory provisions for breaches of contractual and non-contractual obligations.(2) We are liable for damages, regardless of legal basis, in cases of intent and gross negligence. In cases of simple negligence, liability shall exist only:
a) for injury to life, body, or health;
b) for breach of a material contractual obligation, limited to foreseeable, typical damage.(3) These liability limitations also apply to breaches by persons whose fault we are responsible for under statutory provisions. They do not apply in cases of fraudulent concealment, assumption of a guarantee, or claims under the Product Liability Act.(4) The customer may withdraw from or terminate the contract due to a non-defect-related breach of duty only if we are responsible for the breach. Any free right of termination by the customer is excluded.(5) In any case, liability is limited to the agreed order value.§ 8 Data Protection(1) Personal data are processed in accordance with applicable data protection laws. The controller within the meaning of Art. 4(7) GDPR is Dr. Susanne Merk Medical Writing, Kosthofstr. 35b, 82205 Gilching, Germany.(2) Personal data are collected and processed solely for contract performance pursuant to Art. 6(1)(b) GDPR. Failure to provide such data may prevent contract conclusion.(3) Appropriate technical and organizational measures are maintained to protect personal data.(4) Data subjects have rights of access, rectification, erasure, restriction, data portability, and objection pursuant to Arts. 15–21 GDPR.(5) Personal data shall not be disclosed to third parties without consent unless legally required.(6) Processing for purposes other than those stated herein is prohibited.(7) Requests relating to data processing should be directed to the contact details above. Further information is available in our privacy policy at [insert URL].(8) Where personal data are processed on behalf of the customer, such processing shall be governed by a data processing agreement pursuant to Art. 28 GDPR.§ 9 Governing Law and Jurisdiction(1) The contract shall be governed by the laws of the Federal Republic of Germany, excluding the UN Convention on Contracts for the International Sale of Goods (CISG).(2) Exclusive jurisdiction for all disputes arising from the contractual relationship shall be Gilching, Germany, provided the customer is an entrepreneur, a legal entity under public law, or a special fund under public law.