Medical BioTech

HealthCare
Diagnostic, Monitoring, Imaging
Pharmaceutical, Surgery
Reeducation, Assistance, Wellness

Familiar with Medical Environment and relevant
Quality requirements,
ALCYM is competent to properly conduct the design
of your future Medical Device and support
Prototyping and possibly Production via its
outstanding partners.

News

RDV Carnot

Alcym will be at the RDV Carnot in Lyon, the 17&18 october

En savoir plus

BPI Excellence

ALCYM is member of "BPI Excellence" and "Pôle Véhicule du Futur"

 

Advantageous direct tax credit in France.
Thanks to our accreditation you can recover benefits on all our R&D Services.

« Technical World to serve Human Being » ; this slogan expresses the real dimension of MedTec and motivation of people involved, concentrated on Medical Devices and Biotechnologies.

MedTec is a new source of innovation for Medicine.

Still preoccupied by better care and shinning life, MedTec and Biotechnologies crystallize progress of different universes, continuously opening new perspectives for Medicine advances.

In return, Medicine is a real source of inspiration for Technical field.

At the heart of health care concerns and at the crossing of sciences, Medicine is naturally gathering energies around a generous and rewarding cause, stimulating reflexion and encouraging perfection.

Contributions of MedTec to Medicine are proven and plentiful, starting with better Processing Efficiency and Economical advantage, and continuing with Quality, Safety and healthcare Comfort.

+ Efficiency : Assistance, Monitoring, Processing Speed (prompt results), Interaction, Individualization (targeted therapeutic).
+ Economical : Diagnostic (early check, test campaign, preventive care), Calibration (care, dosage), limited Hospitalization (home care).
+ Quality-Safety : Hygiene (consumables), less risk of Infection (limited exposure, cross transmission, nosocomial diseases), Accuracy (instrumentation, diagnostic, imaging), Transparency (monitoring, documentation, traceability).
+ Comfort : Immobilization reduced, handicap Mitigation (assistance, renewed independence), Recovering (feeling, capabilities),

Life expectancy and conditions.

In our everyday life, MedTec has generated a collection of disparate inventions, commonly named ‘Medical Devices’, passive or active, external or implantable, interactive or miniaturized, including for instance syringes, orthopaedic implants, hearing aids, pacemakers and also variety of devices dedicated to diagnostic or imaging.

Willing to properly serve your projects,

ALCYM confirms his know-how and MedTec orientation, moving forward with expected culture and qualities, for instance :

  • Reassuring Experience : successful projects, personal background, customer references.
  • Familiar with medical Environment : microbiology, human aspect, hospital context.
  • Sensitive to applicable standards (IEC60601, ISO13485, ISO14791, IEC62304) and Directives (MDD 93/42/EEC, RoHS)
  • Methodology and Discipline : Planning, Functional Analyses, Risk Analyses, Qualification (V&V).
  • Documentation : Specifications, Design History and Justification (DHF), Technical Definition File (DMR), Production Traceability (DHR).

Here below is a overview of our considerations and attentions specific to this Environment :

FOCUS CONSIDERATIONS ATTENTIONS DESIGN SOLUTIONS
MECHANICS Robustness, Acuracy Stiffness, Distortion Structure, Simulations, Tuning.
Safety Access, Risk of Agression Shapes, Finishing, Protection.
Microbiology Sterilization, Cleaning Materials, Consumables.
Chemical Resistance Environment, Redox Materials, Coatings, Design.
Biocompatibility Implants, Consumables Materials (Stainless, Plastics, Peek,…).
Ergonomics, Noise Feelings (visual, touching) Actuators, Design, Demonstrator.
Scale, Miniaturization Sizing, Assembly, Frictions Components, Construction, Process.
ELECTRIC
ELECTRONICS
Motion, Cabling Performances, Mobility Actuators, Battery, Flex, Connectors.
Pwr Supply, Consumption Power, Sources, Life-time Calculations, Components, Standby.
Safety Standards, Heating Insulation, Protection, Dissipation.
Resistance Environment (TH, Vibration) Coating, Soldering, Bonding, Gluing.
Radiation, EMC Sensitivity, Immunity Components, Shielding, Trials.
Miniaturization Sizing, Assembly, Implants Components, PCB Layout, Flex
SOFTWARE Architecture Visibility, Standards Language, Writting, Documentation.
Safety Failure, Defects, Standards Analyses, Qualification, Approval.
Interface Interaction, Visual, Friendly Graphic, Demonstration, Trials.
Communication Security, Speed Protocoles, Uni/Bi directional.
QUALITY Management Organization, Standards Procedures, Planning, Tracking.
Specification User need, Technical input URS, Functional Analysis.
Analyses Risks, Reliability Evaluations, FMEA.
Qualification Verification & Validation Reviews, Check, Testing, IQ-OQ-PQ.
Documentation Definition, Standards Technical File, DHF-DMR-DHR.