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
  •   Computer System Validation (CSV)

 

 

Dr. Hekmat CONSULTING

www.hekmat-consulting.de

 

Interim Management & effective Consulting 

Regulatory Affairs & Quality Management, Class III Medical Devices & Combination products

 

30 years of effective Strategic & Operative expertise in Clinical & Regulatory Affairs plus Quality Management for Medical Devices industry. Market Access, within the medical fields of Arterial implants, Cardiology, open Heart & Vascular Surgery,  Ophthalmology, Neuro-stimulation, Orthopedics, Dental Care, Modern Wound Care, Regional Anesthesia, Minimal Invasive Surgery, Navigated Robotic Surgery, OCT, CT & NMR digital Imaging (3D), and in vitro Diagnostics.

Technical Documentation (DHF, DMR, DHR), STED,  including Analysis & Evaluation of Product Function & Safety, Biocompatibility, Packaging, Labeling (UDI), Sterilization, Laboratory results, Software & Hardware.

Compliance to applicable Standards (ISO, IEC, EN, MIL).

Certifications acc. current EN ISO 13485 Quality Management Systems, 

GMP, GCP, GLP, GDP,  

Manufacturing Process Verification, Validation (IQ, OQ, PQ).

Product & Production-process Risk Management from Design to market  (Risk Analysis & Risk Control), including Artificial Intelligence, &  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

https://www.hekmat-consulting.de/

 

VAT-ID / USt-ID: DE295239280

Tübingen, Germany  (Stuttgart area) 

DUNS number 313240073

Email:

anusch.hekmat(at)gmail.com

hekmat(at)hekmat-consulting.de 

secure email: A.Hekmat(at)protonmail.ch

Mobile: +49 170 8530715

Skype: anuschirawan.hekmat

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

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