Our extensive

Consulting Portfolio

Medical Device Product Life Cycle
focused consulting
Pharma Product Life Cycle
focused consulting
 
From A to Z

A
Audit Management
Audits - Suppliers
Audits - Software Manufacturer / Supplier
Audits - Sterilization service provider
Audits - internal audits
Audits - MDSAP Preparatory Audits
Audits - Hosting Provider
Audits - Cloud Provider
Audits - Laboratories

B
Biocompatibility (implementation, optimization)

C
CAPA - implementation, optimization
Computer System Validation
CAQ System Validation

D
data integrity
Analysis and evaluation of processed data
Preparation of a compliance plan
Support and implementation of measures for data integrity of processes and systems
Expert seminars to sensitize the responsible persons and participants - also on site at your premises
DMS Document Management System Validation

E
ECM System Validation
EQMS System Validation
EU Medical Device Regulation (MDR)
Equipment Qualification

F
FDA Mock Audit

G
GDP compliance

H

I
IT Infrastructure Qualification

J

K
Adhesive Process Validation

L

M
Methods Validation
Medicine App Compliance
Medical Device Regulation (MDR)

N

O

P
process validation
Test Equipment Capabilities Gauge RR
PMS Post Market Surveillance
Periodic Review

Q
Quality Management, Quality Management System Implementation and Optimization ISO 9001:2015, ISO 13485:2016, 21 CFR Part 820
Qualification of equipment
Qualification of machines
Qualification of IT infrastructures
Qualification of clean rooms
Qualification of media supply (compressed air, water systems, gases etc.)

R
Clean room qualification

S
SAP validation
SAP S/4 HANA Validation
SAP ECC Validation
SAP GTS Validation
SAP LES Validation
SAP Solution Manager Qualification
Statistical methods
Sterilization / Sterilization Processes
software validation

T

U
Unique Device Identification - UDI (EUDAMED, FDA)

V
Validation of processes
Validation of computer-aided systems
Validation of methods
Validation of design methods
Validation of analytical methods
Validation of bonding processes
Validation Cloud Computing Systems
Validation of ERP systems
Validation of ECMS systems
Validation of EQMS systems
Validation of DMS systems
Validation CAQ Systems
Validation of MES systems
Validation of LVS systems
Validation of systems for electronic signatures

W

X

Y

Z