Medical device stand-alone software including apps

 

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.

 

 

https://www.gov.uk/government/publications/medical-devices-software-applications-apps

 

 

 

 

 

Example of CE-marked stand-alone software:

BaLM software for assessment of low-vision

 

 

 

 

Contact us for effective Software-Validation:

 

  •   Medical Device Software
  •   Stand-alone Software used as medical device
  •   Manufacturing Software
  •   Enterprise Resource Planning (ERP) Software

 

 

Dr. Hekmat CONSULTING

www.hekmat-consulting.de

 

Consulting   & Interim Management

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

www.hekmat-consulting.de

 

USt-ID Nr.: DE295239280

 

Im Brühl 10/1, 72144 Dusslingen, Germany  (Stuttgart area)

Email:

anusch.hekmat@gmail.com

hekmat@hekmat-consulting.de 

secure email: A.Hekmat@protonmail.ch

Mobile: +49 170 8530715 

Phone:  +49 7072 800 5600 

Skype: anuschirawan.hekmat

https://www.linkedin.com/in/anusch-hekmat-phd-648a9423/

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