Packaging

Packaging for terminally sterilized medical devices

 

 

ISO/TS 16775:2014

Guidance on the application of ISO 11607-1 and ISO 11607-2

 

Technical Report

 

 

 

ISO 11607-1

 

Requirements for materials, sterile barrier systems and packaging systems

 

ISO 11607-2

 

Validation requirements for forming, sealing and assembly processes

 

Source:  http://www.beuth.de/en

 

The 3 items shown above are only examples of applicable standards for medical device packaging.

 

 

Contact me to develop, test, validate and re-validate your medical device packaging. This will be coordinated with your current suppliers and/or new supplier(s).  

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

Mobile: +49 170 8530715

Skype: anuschirawan.hekmat

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