Medical devices are products that require control and directly affect human life.
Electrical medical devices are tested according to EN 60601 standard according to the current Medical Device Directive.
Medical Device is a product that is used alone or in combination, including instrument device material software to be used on humans.
Sterilization tests, Biocompatibility tests, Clean room tests, Material tests
You can consult EUROLAB Laboratory experts about our 17025 accredited testing services in accordance with the medical device regulations.
Whether your electrically operated medical devices are safe or not, there is a great need for organizations that manufacture electrical medical devices that determine the risks associated with IEC 60601-1 standard medical devices. At EUROLAB Laboratory, we conduct medical tests to ensure compliance with this standard.
In terms of our EC 60601-1 compliance test examination services, we, as EUROLAB Laboratory organization, are experienced by our experienced expert team;
»Compliance with IEC 60601-1 standards and ISO 14971 rules for performance and risk analysis required
»Test consulting
»Creating the required documents
»Product labeling
Information about Electrical Medical Devices
Information on electrical medical devices, IEC 60601-1 standard, electrical medical devices, not connected to more than one power point, used in the diagnosis, treatment and monitoring of the disease together with medical advice, preparing the electrical or physical connection with the patient, performing energy transfer from patient to patient and it is expressed as a device that determines the extent of energy transfer to or from the patient. You can contact our EUROLAB Laboratory for testing electrical medical devices.
IEC 60601-1 has become a global benchmark for electrical medical devices and as a certification body with many companies, IEC 60601-1 compliance, product registrations of many markets UL, CE, and CSA stamps; We deem the need to defend bidders and claims made in case of problems. With the last update, clause 1.3, IEC 60601-1:2005, made it mandatory to comply with all supplementary standards in order to ensure compliance with the basic standard IEC 60601-1.
Some Risks Related to Medical Devices
»Large-scale currents reflected in electric shock to the patient or user (due to possible risks, safety agencies have set a standard for the maximum current rating from perfect products)
»Ventricular fibrillation due to device leakage
» Burns from tools that frequently perform surgical procedures
»Physical temperature rise due to abnormal functioning of the design
»Respiratory disorders caused by abnormal functioning of ventilation
Some Needs of Standards
Mechanical Needs: For example; Is the product sufficiently resistant to cycle, wear and tear?
Stamps: IEC 60601 stated that the electrical requirements of the product, model number, information containing the manufacturer's organization should be included in the product. In addition, IEC 60601 describes test protocols to prevent seals from being erased and worn out quickly.
Grounding: This explains how the product should be connected to the ground or the safety zone that will generate electrical power during an electrical failure.
Electrical Compliance standards require medical systems to operate safely, not only under normal conditions, but also in what IEC calls single error. The IEC 60601 regulations require that there are no safety faults such as fire and death from electric current in the event of single faults.
If you are interested in our FDA 510 k fuel cell services as EUROLAB Laboratory, you may also be interested in the following services,
»CE certification of medical devices
»CB draft approvals
»QM systems approval certificate for operating medical products up to C-critical level and in risk classes
»Medical product safety
»AIMD
»MDD
»PAL
»Approvals between countries
»GM stamp
»Canadian CMDCAS
»GMP approval certificate
»IVDD regulation
»EMC, EN ISO 13485 (and EN ISO 9001)
Calibration and verification of your medical equipment
Whether it is a sphygmomanometer, radiation thermometer or audiometer, with the calibration and verification of your medical equipment; Are you sure that your medical devices have an acceptable level of error in measurements? With the expert team of the EUROLAB Laboratory, we offer advice on safety and quality testing of your medical equipment and certify their reliability in legal registrations to medical devices. Each of the tested devices is supplied in separate barcodes.
Our Services at a Glance
As EUROLAB Laboratory, our expert team allows you to measure the reliability of your medical devices:
»Since we upload test data to your device management software, it allows you to save time in your technical documents.
»As the Standards Office and EUROLAB Laboratory, we work with accredited test laboratories so that you have all your services from a single source.
»You have a special security package with additional test services
»Never miss another analysis
»Identify what is needed for repair and ask only those required
»Provide legal security by fulfilling your responsibilities as a medical device operator
»To seek the assistance of the country's leading service provider in medical technology
»Our testers have no intention of making or selling costly repairs so you can save money
»Ensuring technical quality, accurate diagnosis and safety of both device operators and patients
Calibration and verification of your medical equipment
Metrology Testing for Medical Equipments
As EUROLAB Laboratory, our metrology testing services to medical equipment, with our expert team, carry out internal inspections of your equipment. Tests; apply according to the regulations of the manufacturer and standards.
EUROLAB Laboratory;
»Obtaining advice on the responsibility of various regulations for medical devices
»From visual inspection, performance and quality testing and selection of compliance with limits for measurement errors
»From a final assessment and discussion, including information on safety-related defects
»Without documenting the results with statistics and test reports
»Without marking each of the devices under test with unique barcodes
»We are obliged to assign data to device management software and to compare it with master data.
As EUROLAB Laboratory organization, our medical device metrology test (mt) service standards are at the bottom.
»MPBetreibV
»Law on Medical Devices (MPG)
»Metrology test guide for medical measuring instruments (LMKM)
»Medical Device Operators Regulation (MPBetreibV)
At EUROLAB Laboratory, we have metrology testing of medical technology.
»Thermometers
»Blood Pressure Monitor
»Audio and speech audiometers
»Temperature sensors
»Infrared radiation thermometers
»X-ray equipment
»Foot ergometers
Safe Implants
High-quality implantable medical devices, such as safe implantations, cochlear implantation or heart acceleration, give your patients a new quality of life. The EU 90 / 385 / EEC legislation specifies requirements relating to implantable active medical devices on the European market. As a recognized accredited laboratory organization, EUROLAB Laboratory performs compliance analyzes for your active implantations.
Depending on your needs;
»We analyze the product design and audit your quality management system.
»We carry out an EC-type analysis to assess your quality assurance in the manufacturing arena.
»We perform EC verification.
Our Services at a Glance
As a EUROLAB Laboratory organization, you will receive product approval certificates from us;
»You can get the trust of your customers with the reliability and quality of your active implantations.
»You can benefit from our fast analysis environment and many years of experience.
»You can supply the necessary requirements for the construction of your products in the European market.
Services for Active Medical Devices
We carry out analyzes for compliance with the conformity stated in the annexes 2, 3, 4 and 5 and the regulations of 90 / 385 / EEC which are relevant to our services for implantable active medical devices. To benefit from our services, please contact the EUROLAB Laboratory.
Product Design Experiment Example of Compliance Analysis Procedure Expressed in Appendix 2 on behalf of AIMDs
EUROLAB Laboratory analyzes all of them. If the test is successful, our approval organization will issue you an EC design test certificate.
Elective Review
Our type of examination is made entirely according to your requirements. As SYSTEM QUALITY certification body, our expert team gives you an inspection report related to your possible development areas.
Initial Approval Review
1. Step
Our examinations are conducted at your work sites to determine whether you are qualified for an approval certificate, or to assess the information relevant to your organization. For example, this step evaluates your quality management certificates. The results are presented to you as a report.
2. Step
Before the review, you are given a review coordination. During the review, it is determined whether your stages are compatible with the requirements of the appropriate legislation and standards.
Particular care is taken to ensure that your products meet these needs. Every relevant manufacturing application is included in the scope of this review. Our review team also includes an expert on your product category and categories. Finally, you will receive a detailed review report.
Approval and Certification
If the results of the reviews are positive, you will receive a confirmation that your compliance analysis has been approved. This phase continues with regular 12 monthly surveillance review and re-approval and certification presented every 5 year.
Declaration of Compliance
Once the review is positive, you can declare that your products are compliant and put them on the market with the CE Mark (0197), which includes the information of the recognized authority.
Based Compatibility Analysis in the Implantable Active Medical Device Supplement 2
Compatibility analyzes based on the additional 2 for active implantable medical devices should be reviewed by the designated EUROLAB Laboratory, each product recognized. Most manufacturers determine the compliance review procedure. This procedure also includes reviewing your design file. Since the analysis of the design file will take a long time, you can contact us as the EUROLAB Laboratory organization, which is an authorized authority recognized before the procedure for the implantable active medical devices to the manufacturing organizations.
Active Medical Device Product Examples
Below you will find examples of implantable active medical device products.
»Insulin pumps
»Heart acceleration systems
»Implantable sensory devices
»Retinal implantations
»Cochlear implants and accessories
»Implantable insulin pumps
Special Inventory of Medical Devices and Equipment
Whether the defibrillator for specific special methods, whether for special equipment such as endoscopy device as a special inventory of medical devices and equipment; how can you improve certification in your doctor or clinic? Our team of experts at EUROLAB Accredited Laboratory can help you prepare an official inventory of your medical equipment and devices, or help you update your device management software with test and master data inputs.
Our Services at a Glance
As a technical certification partner, EUROLAB Laboratory provides:
»You can have barcode definition for your medical devices.
»You can update your device management software.
»You can request assistance from a team of experienced medical technicians with long years of experience in documentation.
»Thanks to the updated inventory, you never miss the deadline for the actual audit.
»You can benefit from the legal certification of medical devices in your clinics by the regulations of medical device operators.
»You can have different presentation and analysis formats such as data discs or statistics tables with test reports in pdf format
»From a reputable organization; you can have all the services from installing device management software to helping you create legal documents.
»By combining the steps to be taken, you can optimize your management phase. Inventory can also give you the opportunity to test your medical devices and determine your investment volume in this way.
Legal Standards of Medical Technology
You can find below the legal standards of medical technology in the certification of EUROLAB Laboratory and testing consultancy.
»Regulation on medical device operators
»Regulations on medical device operators (MPBetreibV)
»Laws on medical devices (MPG)
»Safety regulations with equipment inventory
»Inventory required for all efficient, non-implanted medical devices
Overview of Medical Technology and X-Ray Technology Evaluation
A New Perspective on Corporate Values
With regard to the evaluation of medical technology and X-ray technology, damage analysis and re-investment considerations, how can you find out if it is time to invest in new medical technologies? In addition to the applicability and investment assessments; We also provide evaluation and consultancy services for clinics, medical offices, rehabilitation centers and radiology activities. We support you in promoting the quality management network and meeting the legal requirements that are relevant to the medical device operator.
Our Services at a Glance
With the help of our EUROLAB Laboratory expert team in the field of medical technology:
»You can fulfill your administrative and corporate responsibilities.
»By identifying better management of your resources and risk, you can provide financially efficient solutions.
»You can observe the quality of outsourced services.
»You can maintain and maintain your corporate image.
»You can gain legal security and minimize your operating risk.
»You can benefit from our long-term experience and being neutral during the testing phase.
»You can take advantage of receiving all services from a single source.
»You can earn a special security package supported by additional analysis services.
»Benefit from the help of a leading provider of medical technology.
EUROLAB Laboratory on the standards of medical technology and x-ray technology is at the bottom of our company's services. The following regulations and laws relate to the safety and quality of x-ray machines and medical devices:
»Cleaning needs
»Occupational safety and health
»Regulation on medical devices (MPG)
»Regulation on X-ray technology (RöV)
»Regulation on workplace safety (BetrSichV)
»Regulation on medical device operators (MPBetriebV)
»Regulation on hazardous substances (GefStoffV)
»Regulation on the coordination of medical device safety (MPSV)
»Regulation on radiation protection (StrSchV)
Evaluation of medical and X-ray technology in EUROLAB Laboratory
»Preparation for introduction of new QM or QM certification
»Investment and profitability assessment in medical technology
»Analysis of health facilities in accordance with various regulations including specific guidelines on behalf of medical device operators,
»Damage analysis and valuation,
»Providing personnel with quality management manual for medical technologies. The manual outlines the health care facilities outlined by the commercial side of the entity. It also includes instructions for the correct use of medical devices.
»Police investigations with medical devices, etc. expertise in events
»In-house training activities for general medical technology operators and users
»Re-investment and sustainability assessments in medical technology
In addition to the fact that medical products help to save lives, EUROLAB Labortauvar is an important element of quality and competence in an area of innovation that is constantly changing.
We provide assistance with compliance analysis required to obtain the CE marking, which means you can market your products in EU countries. In accordance with your request, we analyze and certify your quality management networks for compliance with EN ISO 9001, EN ISO 15378 or EN ISO 13485 rules.
At a Glance
1) can benefit from our extensive experience and know-how and quick review.
2) With the brand EUROLAB you can get the trust of your customers against your company in terms of the reliability and quality of your products.
3) can benefit from our experience between countries and our cooperation with responsible countries
4) You can use our services which you can have from different sources in one house
5) Our competent development support helps you to avoid false development strategies and minimize feedbacks.