ISO 13485 certification


CALISO offers professional consulting for medical device manufacturers, including services geared towards 510k approval and CE certification requirements. The following information is about the European Medical Device Directive and how we can help you pass the strict CE certification requirements.

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For Medical Device GMP training, Click here.

The European Medical Device Directive (MDD):

The European medical device directive makes it mandatory to fulfill CE certification requirements in order to export medical devices, of Class I, IIa, IIb, and III to any country within the European community. For U.S. firms, the recommended strategy is to pursue the CE certification while the product is in the approval process by the FDA. The CE certification can be often achieved prior to the FDA's approval, thus enabling the device to be sold in Europe and generating substantial revenues. The requirements for CE certification are very strict but if the product is in advanced clinical investigation or IDE (Investigational Device Exemption) stages by the FDA, the CE certification can happen much quicker than the FDA's.

The new MDD for CE Marking became mandatory on March, 21 2010

This means that all medical device manufacturers have to review their compliance to this directive and be in compliance. OTHERWISE they have to stop selling their devices in the European community. This is especially critical for the new classification rules, if a Class I device is now classified as Class II a or b, or from Class II to Class III, a new conformity assessment is required. So it is URGENT to conduct a review of your technical file to the new MDD requirements and classification rules, or risk having to stop selling the device.

Medical Device classification in a nut shell (see 93/42/EEC updated for 2010):

The classification is similar to the FDA's, except for the sub-classification of (a) and (b) for class II products. Class I is for low risk device, while Class III is for the higher risk devices. The Classification is addressed in detail in 93/42/EEC Annex IX. Here are examples of classifications:

  • Class I:
    Wheel Chairs Patient electrodes. Scalpels. Dental Drills. Wound Management systems. Hearing Aid Tester.

  • Class IIa:
    All patient monitoring equipment, Syringes. Needles. Ultra Sound devices. External ECGs. Diagnosis devices mainly.

  • Class IIb:
    Lasers Devices for application. Internal ECGs. RF Generators. Non-energized implants. Treatment devices mainly.

  • Class III:
    Energized implants All Intracardiac applications. Heart valves. Cauterters. Non-energized implants. All devices in contact with the central nervous system.

Recommended compliance routes:

  • Class I
    • Hold a Technical file*
    • Self-Declaration of Conformity according to Annex VII.
    • Observe provisions of the procedures referred to in Annex IV, V or VI of 93/42/EEC for "sterile" or "Measuring" function devices.
    • Apply for CE mark.
  • Class IIa & IIb
    • Hold a Technical file* Obtain ISO 9001/EN 46001 certification.
    • Audit by notified body according to Annex II. Apply CE mark.
  • Class III
    • Hold a Technical file* Obtain ISO 9001certification.
    • Audit by notified body according to Annex II.
    • Product Dossier Exam by notified body according to Annex II. Apply CE mark.

*Technical File Content:
General product description Design drawings, methods of manufacture and diagrams of components and sub-assemblies. Description and explanation of above-mentioned drawings and diagrams. Result of risk analysis and list of standards referred to in Article 5 of 93/42/EEC, applied in full or in part, and descriptions of the solutions adopted if not applied in full. Description of the methods used if the device require sterility. The results of the design calculations and of the inspections carried out. If the device is to be connected to other device(s), proof must be provided that it conforms to the essential requirements when connected. The tests reports and where appropriate, clinical data in accordance with Annex X of 93/42/EEC. The label and instructions for use.

The services we offer:

CALISO will assist in preparing and the technical file or Product Dossier to obtain your CE Certification. We can parallel process the implementation of a quality management system in compliance with the ISO 13485 and ISO 14971.
NOTE: Registrars and notified bodies sometimes offer a different service called "Technical File Reviews". This service is limited to a review of the final draft of the technical file. They in NO WAY are allowed to assist or advise you on the how to prepare your technical or product dossier. Our services include assistance in establishing AND final submittal of your Technical file.
Among the companies we helped in their certification and compliance projects:

The services will be performed to GMP/QSR and ISO/EN requirements and includes protocol & report development, training and implementation for any class 1, 2 or 3 (FDA) and I, IIa, IIb, III (CE).

Manage all your Quality Assurance and Regulatory functions on a subcontract basis including:

  • Liaison with notified bodies and competent authorities in EC.
  • Auditing against MDD and essential requirements.
  • Assisting with clinical investigations to meet multi-national requirements and conformance with EN 540 and US FDA GCP requirements.
  • Be you representative in the EC.
  • Assist in Vigilance reporting.
  • Registration of distributed products with competent authorities in each EC country.
  • Customer Complaint handling in EC.
  • Notifying competent authorities of, and managing clinical trials.
  • Process Validations (IQ/OQ/PQ/PPQ)
  • Software Validations.
  • Packaging & Shelf Life Validations.
  • Failure Modes & Effects Analysis .
  • Quality Systems Audits.
  • CE Technical File Generation.
  • Statistical Methodologies & Training.
  • Measurement Systems Validation.
  • Sterilization Validations.
  • Biocompatibility Testing.
  • GMP Compliant Manufacturing Systems.
  • Environmental Cleanroom Controls.
Click on the link button below to fill-in information about your product and request a proposal or additional information:

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