Dr. Hekmat      Consulting & Interim Management

Introduction to Dr. Hekmat Consulting & Interim Management 

At Dr. Hekmat Consulting, we specialize in navigating the complex world of global regulatory affairs and quality management for innovative medical devices. With extensive knowledge of the European, American, and Asian markets, our team provides strategic and operative expertise to propel medical technology from conception to widespread clinical use.

Our Expertise

Our accomplishments include:

• Qualilty Management System approvals
• Successful multicenter clinical studies
• Securing numerous Marketing approvals
• Mastery in regulatory affairs, with a deep understanding of class III medical devices
• Unparalleled guidance navigating international medical device regulations

30 Years of Experience

We have 30 years of experience in providing effective strategic and operative expertise in regulatory affairs and quality management for the medical devices industry, with a focus on global market access. Our expertise spans various fields, including:

• Cardiology
• Heart Surgery
• Neuro-stimulation
• Orthopedics
• Ophthalmology
• Dental Care
• Modern Wound Care
• Regional Anesthesia
• Minimal Invasive Surgery
• Navigated Robotic Surgery
• Imaging (CT, NMR, OCT, ultrasound)
• Vascular Intervention
• Class III medical devices
• In vitro Diagnostics

Certifications and Compliance

We support Quality-Management-System Certification according to EN ISO 13485 and have experience with consumer product certifications according to IFS-HPC, IFS-Broker, and IFS-GM. We ensure compliance with applicable standards, including ISO, IEC, EN, AAMI, and MIL, as well as GMP, GCP, and GLP.

Services

Our services include:

• Qualilty Management System acc. ISO 13485 incl. QMSR 
• Technical Documentation on medical devices (eCTD, DHF, DMR, DHR, STED)
• Analysis and Evaluation of Product Function and Safety
• Biocompatibility, Packaging, Labeling (UDI), Sterilization, and Laboratory tests
• Software and Hardware validation (CSV, ERP)
• Preclinical and Clinical evaluation
• Post Marketing Surveillance (PMS) and Post Market Clinical Follow-up (PMCF)
• Risk Management (Risk Analysis and Risk Control) of Product and Production-process
• Clinical Evaluation, Clinical Study Organization, and Ethics Committees (IRB)
• Audits and Evaluation of Production Processes and Suppliers
• Medical Device Reporting to Competent Authorities
• Corrective and Preventive Action (CAPA) and Non-Conformity (NC) management
• On-site Support during Notified Body audits, GMP and US-FDA inspections
• Reimbursement schemes

Results

Our effective stragegic & operative management has led to Quality Management System approvals, and to many medical devices Marketing Approvals in the EU, Americas, and Asia.

We also provide expertise in Consumer Products, including International Featured Standard IFS-HPC v3, Forest Stewardship Council (FSC), and Roundtable on Sustainable Palm Oil (RSPO).

Dr. Hekmat CONSULTING 

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

Tübingen, Germany  (Stuttgart area)

anusch.hekmat(at)gmail.com

hekmat(at)hekmat-consulting.de

Mobile: +49 170 8530715 

VAT-ID / USt-ID Nr.: DE295239280 

DUNS number 313240073 

www.linkedin.com/in/anuschirawan-dr-hekmat-648a9423 

https://www.xing.com/profile/Anuschirawan_HEKMAT2