Approval of your Medical Devices
The marketing of medical devices (MD) and in vitro diagnostic medical devices (IVDD) is associated with regulatory frameworks that must be respected in Europe and in most countries of the world.
We support you throughout the life cycle of your medical device by aiming to respect your marketing schedule and by proposing solutions to bring a more mature product to market.
From prototype to conformity production !
We support you throughout the life cycle of your MD
- Risk analysis: ISO 14971, FMECA
- Software: IEC 62304
- Cybersecurity:
IEC 81005-5-1, IEC TR 60601-4-5 - Electrical/CEM: IEC 60601-1, EN60601-1-2
- Usability to use:
IEC 62366-1, IEC 60601-1-6 - Medical Device (MD) Regulation: EU/2017/745
- In Vitro Diagnostic Medical Device (IVDD) Regulation: EU/2017/746
- Implantable device: EN 45502-1, ISO 14708)
- Biocompatibility: EN ISO 10993-1
- Clinical study: EN 14155
- Machine Directive regulation: 2006/42/EC
- Regulatory affairs
- Technical file CE marking
- Dossier submission - FDA/510(k)
- Regulatory analysis according to EU/2017/745 (DM)
- Regulatory analysis according to EU/2017/746 (IVDs)
- Post-production, market surveillance
- Risk analysis
- ISO 14971, FMECA process
- Gap-Analysis of the risk management file
- Gap-Analysis of the fitness-for-use management file
- Gap analysis of the software management file
- Gap-Analysis of the cybersecurity file
- Quality Assurance
- Blank audit of the quality system
- QMS construction assistance
- Clinical evaluation
- Review of clinical evaluation plans and reports
- Follow-up of clinical evaluation files
- Process Validations
- Sterilization process
- Disinfection process
- Decontamination process
- Cleaning process
- Packaging
- Definition of technical normative references
- Identification of normative requirements on customer specifications
- Analysis of the design choices in relation to the requirements of the standards
- Customization of tests in relation to the environment of use of the equipment defined by the customer
- Specification of safety parameters to be taken into account in the customer's development
- Specification of parameters to be taken into account in the risk management file
- Assistance in the consolidation of design budgets
- CE marking
- Direct use of test reports for class I DM - Self-certification approach
- Submission of test reports to the Notified Body for class II A and higher
Certification process - Assistance in drafting the EC technical file, regulatory support, demonstration of compliance with general safety and performance requirements
- CB scheme
- Validated by the Emitech Certification Body, the reports give you access to more than 50 countries
- Approval on a range of destinations
Tailor-made support to sell worldwide
- Access to certification marks
- Test program flow from standards to be applied for medical guidelines
- Basic standards IEC 60601-1
- Collateral standards 60601-1-X2 - electromagnetic compatibility,
4 - software life cycle (IEC 62304),
6 - fitness for use (IEC 62366-1)
8 - alarm system,
9 - ecodesign,
10 - automatic regulation, control loop,
11 - home care,
12 - emergency care
... - Specific standards 60601-2-X or 80601-2-X
10 - electro stimulator,
18 - endoscope,
49 - multifunction
52 - medical beds,
57 - light therapy
77 - robotic surgery
...
- for additional directives
Radio standards e.g. for the RED directive
- Validation of the EM system installation
- Validation of the operating environment
- Trapping zones
- Functional tests
- Machine directive tests - 60204-1 (robot...)
Engineering
Risk |{br|} analysis
Support IEC 60601-1 / ISO 14971
Software / Cybersecurity
Documentary review (IEC 62304 / IEC 81005-5-1, IECTR 60601-4-5)
Usability|{br|}to use
Documentary review (IEC 62366-1)
Project management
Coordination of project follow-up by technical staff
We offer a global approach through our project management or during the key stages that you wish to entrust to us.
We extend the expertise brought by our laboratories in security, EMC and radio by our engineering and technical assistance allowing you to approach serenely the documentary aspects.
Identification, marking, doc.
Review of the requirements of §5 of IEC 60601-1-2
Standards, test methods...
To be approved in Europe and the rest of the world, DMs must comply with tests covering multiple areas: electromagnetic compatibility (EMC), radio, EMF (Electromagnetic field), safety, climatic or mechanical.
Main safety standards for electrical equipment
- IEC 60601-1 / EN 60601-1 # Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-2-XX / EN 60601-2-XX / IEC 80601-2-XX / EN 80601-2-XX # Medical electrical equipment - Part 2-xx: for safety and essential performance
- IEC 60601-1-XX / EN 60601-1-XX # Medical electrical equipment - Part 1: Particular requirements for collateral standards
- Analysis of deviations by country (example: UL 60601-1 / AAMI ES60601-1 / CSA C22.2 No. 601.1, deviation for North American countries)
The 60601 series of standards includes 60601-1 and 60601-2-XX / 80601-2-XX. Part 1 applies to all medical products, while Part 2 addresses specific requirements for a particular type of medical device. There are over 40 Part 2s (60601-2-XX, 80601-2-XX).
The 60601-1-X standards deal with specific tests such as those related to electromagnetic compatibility requirements, radiation...
Main standards in ElectroMagnetic Compatibility (EMC)
- IEC 60601-1-2 / EN 60601-1-2 # Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances
- IEC 60601-2-XX / EN 60601-2-XX # Medical electrical equipment - Part 1-2: Particular requirements
-
Basic security and essential performance
Documentation analysis
Usability / software analysis
Verification of essential performance
Protection against electric shocks
Insulation tests / Dielectric strength
Heating
Leakage currents
Creepage distances and distance in air (MOOP/MOPP)
Resistance to humidity
Protection against mechanical shocks
First fault condition testing
Protective grounding means
Fire resistance of enclosures
Impact resistance
Drop/tilt tests
Entrapment zones
Mechanical stops
Alarm systems
-
Emission / immunity
Radiated Emission - Measured at 3 m in FAR cage or at 3 or 10 m in SAR or in free space site)
Conducted emission
Immunity 10 kHz to 6 GHz
Radiated immunity (in SAR or FAR)
Conducted immunity
Magnetic immunity
Electrical testing
A complete range of test equipment according to EN 61000-4-(2, 4, 5, 8, 9, 10, 11, ...) and EN 61000-3-(2 and 3) - EN 61100-3-(11 and 12)
Electrostatic discharge up to 30kV
Fast transients in bursts
Shock waves
Voltage dips, short interruptions and voltage variations
Emission of flickers and harmonics
-
Radio - Spectrum Management
Proper allocation of frequencies and operating channels
Unwanted emissions in the spurious range
...
Mechanical
Vibrations - Shocks
Endurances
...
Climatic and physico-chemical
Hot - Cold - Humidity
IP protection index
Thermal shocks
...
Hydraulics
Fatigue - Mechanical resistance - Pressure variation
...
Acoustics
Sound levels (sirens, alarms...)
...
Robustness
HALT - HASS
Security
and performance
Integration tests
In situ validation
ElectroMagnetic Compatibility
Emission, immunity, electrical tests...
