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)

 

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