medical devices
technical
engineering
equipment, processes and utilities
From user requirements to qualification, production and operations
Engineering study of the phases of Concept Engineering – Basic Engineering – Detail Engineering :
- Procedures
- Mechanical engineering
- Electricity / Automation (GAMP5) / Instrumentation
- HVAC
Commissioning
- Installation monitoring
- Implementation of protocols
- Troubleshooting
Production support and continuous improvement
R&D
medical device R&D
Our expertise is in the main types of medical devices :
- HardWare Engineering : mechanical, electronic
- SoftWare Engineering
- System Engineering
- Design Control (820.30) ) and Design & Development (ISO13485)
- Risk management (ISO 14971)
- Human factors : usability (ISO 62366)
- Verification & Validation
- Industrialisation
Our skills :
- Combination products
- Diagnostic machines
- Implantable medical devices (active or passive)
qualification / validation
equipment, processes and utilities
- Qualification of equipment or utilities :
- Risk analysis (FMECA)
- Drafting the protocols DQ/IQ/OQ/PQ
- Implementing protocols
- Drafting reports
- Validating processes
- Validating cleaning and sterilisation (CIP/SIP/COP)
- Computerized system validation (CSV)
quality
Quality support for R&D or production
- Quality Management System in accordance with ISO 13485/FDA and the group directives
- Quality Assurance (QA) :
- Operational QA: CAPA, deviation, change control, review of batch records, investigations, etc.
- Supplier AQ
- Compliance
- Review and approval of protocols for qualification and validation
- Quality Engineering
- Quality Control (QC) :
- Development / Validation / Transfer of analytical methods and physico-chemical tests
- Biocompatibility issues
- Qualification of laboratory equipment in accordance with GMP or ISO 13485
Standards environment: ISO 13485, ISO 14971, ISO 62366, 21 CFR Part 820, etc
regulatory affairs
Regulatory Affairs :
- Knowledge and mastery of the technical-regulatory aspects of medical devices
- Monitoring of changes in standards and regulations
- Demonstration of compliance in accordance with Directives 93/42/EEC (MD) and 98/79/EEC (IVDMD) and regulations 2017/745 (MD), 2017/746 (IVDMD) and/or FDA and others (MDSAP, CFDA) in force
- Management of accreditation for the purpose of being present on a market (registration and maintenance of CE marking, 510K, etc.).
Postmarket surveillance :
- Medical device vigilance
- Surveillance of customer and clinical feedback
- Surveillance of feedback about maintenance
- Surveillance of communications by the competent authorities and from competitors’ medical devices.
- Setting up and monitoring the required actions (corrective maintenance, market withdrawal, informing the competent authorities, etc.)
project
- Management of engineering projects: new projects or revamping
- Infrastructure & buildings
- Utilities (purified water, water for injection, steam, etc.)
- Equipment (formulation, filling, assembling, Unique Device Identification - UDI)
- Worksite phase: technical coordination and monitoring of implementation
- R&D project management: product development in accordance with the design controls
- Device Engineering : technical coordination for product development
- Risk Management in accordance with ISO 14971
- Technology transfer, production transfer or outsourcing to a CMO, etc.
- Management of quality projects: audit preparation, upgrading of an ISO13485 quality system
- Procurement categories: support for outsourcing for development with CMOs
technical
engineering
equipment, processes and utilities
From user requirements to qualification, production and operations
Engineering study of the phases of Concept Engineering – Basic Engineering – Detail Engineering :
- Procedures
- Mechanical engineering
- Electricity / Automation (GAMP5) / Instrumentation
- HVAC
Commissioning
- Installation monitoring
- Implementation of protocols
- Troubleshooting
Production support and continuous improvement
R&D
medical device R&D
Our expertise is in the main types of medical devices :
- HardWare Engineering : mechanical, electronic
- SoftWare Engineering
- System Engineering
- Design Control (820.30) ) and Design & Development (ISO13485)
- Risk management (ISO 14971)
- Human factors : usability (ISO 62366)
- Verification & Validation
- Industrialisation
Our skills :
- Combination products
- Diagnostic machines
- Implantable medical devices (active or passive)
qualification / validation
equipment, processes and utilities
- Qualification of equipment or utilities :
- Risk analysis (FMECA)
- Drafting the protocols DQ/IQ/OQ/PQ
- Implementing protocols
- Drafting reports
- Validating processes
- Validating cleaning and sterilisation (CIP/SIP/COP)
- Computerized system validation (CSV)
quality
Quality support for R&D or production
- Quality Management System in accordance with ISO 13485/FDA and the group directives
- Quality Assurance (QA) :
- Operational QA: CAPA, deviation, change control, review of batch records, investigations, etc.
- Supplier AQ
- Compliance
- Review and approval of protocols for qualification and validation
- Quality Engineering
- Quality Control (QC) :
- Development / Validation / Transfer of analytical methods and physico-chemical tests
- Biocompatibility issues
- Qualification of laboratory equipment in accordance with GMP or ISO 13485
Standards environment: ISO 13485, ISO 14971, ISO 62366, 21 CFR Part 820, etc
regulatory affairs
Regulatory Affairs :
- Knowledge and mastery of the technical-regulatory aspects of medical devices
- Monitoring of changes in standards and regulations
- Demonstration of compliance in accordance with Directives 93/42/EEC (MD) and 98/79/EEC (IVDMD) and regulations 2017/745 (MD), 2017/746 (IVDMD) and/or FDA and others (MDSAP, CFDA) in force
- Management of accreditation for the purpose of being present on a market (registration and maintenance of CE marking, 510K, etc.).
Postmarket surveillance :
- Medical device vigilance
- Surveillance of customer and clinical feedback
- Surveillance of feedback about maintenance
- Surveillance of communications by the competent authorities and from competitors’ medical devices.
- Setting up and monitoring the required actions (corrective maintenance, market withdrawal, informing the competent authorities, etc.)
project
- Management of engineering projects: new projects or revamping
- Infrastructure & buildings
- Utilities (purified water, water for injection, steam, etc.)
- Equipment (formulation, filling, assembling, Unique Device Identification - UDI)
- Worksite phase: technical coordination and monitoring of implementation
- R&D project management: product development in accordance with the design controls
- Device Engineering : technical coordination for product development
- Risk Management in accordance with ISO 14971
- Technology transfer, production transfer or outsourcing to a CMO, etc.
- Management of quality projects: audit preparation, upgrading of an ISO13485 quality system
- Procurement categories: support for outsourcing for development with CMOs
clinical and vigilance operations
clinical operations
Altogen helps its clients manage and run their clinical studies, by supplying staff in the following areas :
- Clinical Trial Assistants (CTA)
- Clinical Research Associates (CRA)
- Local/Global Clinical Trial Managers (LTM/GTM)
vigilance
We support our partners in pharmacovigilance, cosmetovigilance, medical device vigilance and nutritional vigilance in the detection of signals and the explanation and prevention of adverse incidents.
For this purpose, our employees work in areas such as MedDRA coding, entering cases into databases, processing adverse incidents and drafting periodical reports (PSUR/DSUR) for our clients.
We are hiring :
For this purpose, our employees work in areas such as MedDRA coding, entering cases into databases, processing adverse incidents and drafting periodical reports (PSUR/DSUR) for our clients.
We are hiring :
- database managers (SafetyEasy, ArisG, Argus)
- pharmacists
