Regulatory Requirements, Standards, Norms & Guidelines

As an experienced regulatory specialist and certification expert, I am familiar with CE, FDA, ANVISA and MDSAP certification systems and requirements. Reimbursement routes such as DIGA, PECAN (France), “Heilmittelverzeichnis” und/oder “Hilsmittelverzeichnis” are well known to me.

• MDR (including software as medical device, textile medical devices: such as orthopaedic devices, wound care, surgical masks and/or surgical- / op-suits)
• IVDR
• swissmedic
• BfArM
• DIGA, HMV, GKV
• PECAN
• S.P.E.L. (Safety and Performance Evidence level)
• REGULATION (EU) 2016/425 (Personal Protective Equipment: FFP2 Masks / FFP3 Masks / Face Shields)
• ISO 13485:2016 (including gap analysis and transition from 13485:2003 to 13485:2016 and MDR)
• ISO 14971, ISO 62366, ISO 14155, ISO 62304, ISO 60601, ISO 10993
• EN 149
• EN 14683
• GMP, GLP, GCP
• ICH
• ASTM
• MEDDEV / MDCG
• IMDRF
• 21 CFR 820
• MDSAP

• Borderline Products / Pharmaceutics / Vaccines (Member of dTIP Expert Circle, ETH Zurich)
• In vitro diagnostics and diagnostic platforms (muscle cells / cancer cells / ATMPs)
• Surface functionalization for implantable devices based on GELATINE / ALGINAT / CHITOSAN / DOPAMIN, etc.
• BioCEMENT / Magnesium Products
• Artificial Bone / BoneGrafts
• POC Solutions
• Niche Products: Chairs, Beds

 

My services: 

Reviewing Design and Development 

Risk Analysis according to ISO 14971

BEP / BER

Usability Engineering

Clinical Evaluation and PMS Strategies

Classifications

Testing and Validation Process

Compiling / writing STED files / CERs

Submissions in various countries

Reimbursement Strategies (GKV / DiGA / PEKAN)

Certification Strategies

AUDITING SERVICES (GMP / GCP/ GLP / ISO)

Technical Pre-Assessment

 

SAMPLE LIST MEDICAL DEVICES

 

Ophthalmologic Medical Devices, I / IIa / IIb / III

 

Software and Hardware, Accessories, Procedure Packs, Combination Products

 

SaMD – Software as Medical Device / AI / DiGA

 

SMART Device

• Combination SaMD AND Wheelchair
• Combination SaMD AND Orthesis
• Combination of SaMD and ophthalmological devices
• Combination SaMD and VR for stroke rehabilitation
• Smart Implant Surfaces
• Smart Geometries
• SMART Applicators
• SMART Syringes

 

Instruments Class I

• Class I
• Class I m [measuring devices]
• Class I s [sterile instruments]
• Class I r (MDR) [reusable instruments]

Instruments Class IIa

• Plasma-Surgery
• Thermofusion
• Intra-Oral-Welding
• Intra-Oral-Scanning
  
  

Dental Implants, Dental Prosthetics and Instruments

 

Prosthesis, Orthesis and Orthopedic Aids & Devices

 

Orthopaedic Implants (Trauma) & Prosthetic

 

Neurological Equipment (Machine Solutions)

 

Surface functionalization for implantable devices

based on HYALORON / GELATINE / ALGINAT / CHITOSAN / DOPAMIN, etc.

 

SAMPLE LIST IVDs

In-vitro diagnostic devices and diagnostic platforms

 

SAMPLE LIST OTHERS

• Paints and Applicators (Pharma and MedTech)
• Wound Care: Haemostatic Devices and/or Plasma-based Devices and/or Cooling Devices
• Wound Care: Haemostatic Powders
• Hernia Meshes: Titanium and/or Polymer
• Cryotherapie (Class IIa)
• Respirators
• Mund-Nasen-Schutz (OP-Maske)
• Filtrierender Filter-Atemschutz ohne Ventil (PPE / PSA)
• Filtrierender Filter-Atemschutz mit Ventil (PPE / PSA)
• Gesichtsschild (PPE / PSA)