Clinical investigation of medical devices for human subjects - Good clinical practice
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011 + Cor. 1:2011); German version EN ISO 14155:2011 + AC:2011
The standard specifies the formal requirements for the performance of clinical investigation of medical devices. It serves particularly for the protection of study populations employed in the investigation. It shall also contribute to scientifically tenable investigation results. This standard is essentially different from the currently applicable standard in the following points. It includes the hitherto independent part 2 of the standard, which specifies the content of the investigation plan. The standard is based closely, as far as it makes sense, on the regulations on clinical investigation of medicinal products, in order to relieve the application for institutions which investigate both medicinal products and medical devices. The responsibility of the sponsors, the doctors (monitors) assigned by the sponsors and the clinical investigator are summarised in separate clauses. This relieves the fulfilment of each task and thereby contributes to correct performance and cost reduction. This standard is directed at manufacturers of medical devices and doctors as well as institutions which perform clinical investigation of medical devices. The European Standard has been prepared by ISO/TC 194 "Biological evaluation of medical devices" (secretariat: DIN) in collaboration with CEN/TC 258 "Clinical investigations of medical devices" (secretariat: DIN) with the essential contribution of German experts. At DIN, the responsible Working Committee is NA 027-02-20 AA "Klinische Prüfungen" ("Clinical investigations") of NAFuO.
See also information on MEDDEV 2.7.1 revision 4:
Contact me for Clinical Evaluation of your medical devices based on scientific peer-reviewed literature (e.g. via http://www.ncbi.nlm.nih.gov/pubmed and other sources).
In case of novel devices, novel materials, novel technology, or missing literature on approved medical devices, I will organize and run clinical studies together with leading medical doctors of your choice, including approval of local Ethics-Committees.
Quality Management & Regulatory Affairs Medical Devices & Combination products
Since 1994, effective Strategic & Operative experience in Quality Management & Regulatory Affairs for Medical Devices industry, within the fields of Ophthalmology, Neuro-stimulation, Vascular Intervention, Cardiology, Heart Surgery, Orthopedics, Dental Care, Modern Wound Care, Regional Anesthesia, Minimal Invasive Surgery, Navigated Robotic Surgery, CT & NMR digital Imaging (3D), and in vitro Diagnostics.
Technical Documentation (DHF, DMR, DHR) including Analysis & Evaluation of Product Function & Safety, Biocompatibility, Packaging, Labeling (UDI), Sterilization, Laboratory results, Software & Hardware.
Compliance to applicable Standards (ISO, IEC, EN, MIL).
Manufacturing Process Verification, Validation (IQ, OQ, PQ).
Product & Production-process Risk Management (Risk Analysis & Risk Control), including Additive Manufacturing.
Clinical Evaluation, Organization of global multicenter Clinical Studies.
Audits of Production Processes & Suppliers.
Medical Device Reporting to Competent Authorities (e.g. BfArM, FDA).
Corrective And Preventive Action (CAPA) / Non-Conformity (NC) / corrective Project.
On site Support in Notified Body audits, and FDA inspections.
Effective management leading to a multitude of marketing approvals in the EU, Americas (FDA), & Asia, including Reimbursement schemes.
Dr. Hekmat CONSULTING
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