Guidance on the application of ISO 11607-1 and ISO 11607-2
Requirements for materials, sterile barrier systems and packaging systems
Validation requirements for forming, sealing and assembly processes
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
Regulatory Affairs & Quality Management, Class III Medical Devices & Combination products
25+ 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 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
VAT-ID / USt-ID: DE295239280
Tübingen, Germany (Stuttgart area)
DUNS number 313240073
secure email: A.Hekmat(at)protonmail.ch
Mobile: +49 170 8530715