Medical devices

Research

Design/calculation study
Clinical assessment
Clinical validation
Packaging validation
Validation of mechanical performance of products
Compliance control of scientific data

Development

Assistance in the creation of design dossiers
Clinical evaluations (with state of the art)
Formalisation of the technical file (applicable regulatory and normative requirements, forecast risk analysis)
Formalisation of design input data
Review of design dossiers
Support in the drafting of materials (user manuals, sales materials, etc.)

Design

Mechanics: design and industrialisation of parts (e.g. orthopaedic implants, instruments, “hardware” elements of electro-medical equipment, etc.), production using CAD software, then production by machining, plastics, foundry, forging, 3D printing, etc.
Electronics: design and industrialisation of electronic components (electromechanical system, electronic cards, etc.)
IT: design (code) of one or part of a computer program considered to be a medical device or part of a medical device.

Process engineering

Risk analysis (AMDEC, etc.)
Industrial maintenance
Process optimisation
Change management
Production support

New works and maintenance

Technical business management (from specifications to the commissioning of equipment/utilities / buildings)
Drafting specifications
Supplier consultations
Technical assessment of responses
Management of subcontractors/Planning
Factory Acceptance Test/Site Acceptance Test
New works & revamping: Infrastructures & buildings Utilities and equipment

Supply Chain

Analysis and monitoring of transport conditions (logistical complaints, temperature excursions, etc.)
Coordination of recalls/ batch withdrawals
Change control and CAPA monitoring at the level of the distribution chain
Establishment/modification of distribution channels
Support for depositaries
Qualification of the suppliers
Monitor the implementation and compliance with BPDG

HSE

QHSE technical supervision (extension projects, maintenance, technical shutdowns)
Implementation of safety receptions, prevention plan and fire permits
Verification of the qualification of the stakeholders
Verification of equipment compliance
Occupational Risk Assessment
Assistance in setting up and monitoring means of protection (EPI/EPC)
Control of the good practice of the applicable standards and instructions (auditing)
Specific tasks: ISO14001: 2015, OHAS18001: 2007, ISO45001: 2018, MASE, ICPE files, chemical risk assessment, ATEX study

QA system

Implementation and Optimisation of the SMQ
Identification and mapping of processes
Deployment of normative requirements and GxP benchmarks, 21 CFR part 820, ISO13485: 2016, ISO9001: 2015
Preparations for inspections (ANSM, FDA) and for internal audits
Implementation and Optimisation of the SMQ depending on the needs of the company
Document management (Writing of SOP, WI, quality manual …) and training
Risk management approach

Operational QA

CAPA Management
Deviations, anomalies, non-conformities and change control
Customer Complaints management
Product quality
Management of production documentation, validation procedures, instructions. Document management tool (Access, Excel, VBA, specialised GED)

Contrôle qualité

Quality Control
Analysis of the end product
Analysis of anomalies, OOS and OOT
Data integrity

Qualification / Validation

Qualification/Initial validation, retrospective and periodical
Equipment (production, conditioning, control), Premises, Utilities
FAT/SAT
Process validation (machining, moulding, coating)
Special processes (surface treatment, cleaning, packaging, sterilisation 11135/11137, biocompatibility 10993)

Validation of Computerised/ Automised systems

ERP, LIMS, MES, 21 CFR part11
Traceability matrix, risk analyses, Validation Master Plan, test plan
Execution of tests (QI/QO/QP), Validation report and production
Data Integrity

Consultation and update of cases

Determination of the class of medical devices
Total creation and upgrading of technical files
Writing of clinical evaluations according to the new regulations (2017/745 & 2017/746) and the MEDDEV 2.7/1 rev 4 guide
EC marking dossier, 510k, export (China, Japan, Mexico)
Risk analysis
Respecting ISO 13485 : 2016

Registration and Submission

Operational and strategic support
Drafting, submission and consideration of comments
Recording Medical devices

Vigilance

Normative and regulatory regulation
Gap analysis
Medical devices vigilance/ Responsive vigilance
Post-Market surveillance
Biocompatibility
Physico-chemical validation (see Validation tests)
Studies and clinical follow-up

Implementation of clinical studies

Drafting of key documents
Submission of documents to the relevant authorities
Managing amendments
Development of clinical trial protocols
Design of clinical studies, pre/post market

Selection and monitoring of CRO

Benchmarking of a pre-defined panel
Logistics of the investigator centres (selection, organisation of training and information, study monitoring)

Post Marketing Surveillance

Medical devices vigilance : management of adverse events
Analysis of clinical data
Clinical studies of post-marking surveillance (PMCF Studies)