Information on when software applications are considered to be a medical device and how they are regulated.
Guidance on what a software application medical device is and how to comply with the legal requirements.
Example of CE-marked stand-alone software:
BaLM software for assessment of low-vision
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
USt-ID Nr.: DE295239280
Im Brühl 10/1, 72144 Dusslingen, Germany (Stuttgart area)
secure email: A.Hekmat@protonmail.ch
Mobile: +49 170 8530715
Phone: +49 7072 800 5600