Packaging

Packaging for terminally sterilized medical devices

 

 

ISO/TS 16775

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: www.beuth.de/en 

 

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

 

 

Contact us to develop, test, validate and re-validate your medical device packaging.

 

This will be coordinated with your current suppliers and/or new supplier(s), and may include labeling.  

 

 

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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