Validations IQ, OQ, PQ

 

Validation of product & production processes (DQ, IQ, OQ, PQ) are required for the Quality Management System, as well as for medical device marketing approvals based on certifications.

Validations include Enterprise Resource Planning (ERP) software, and may include stand-alone medical device software. 

 

 

https://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/ 

qr code

Empfehlen Sie diese Seite auf:

www.linkedin.com www.xing.com
Druckversion | Sitemap
© Anuschirawan Hekmat