For CE Mark and certification of NON-Medical devices and products, Click here.
For Medical Device GMP training, Click here. 
FDA 510K Clearance:
For medical devices classified as Class II or Class III, a 510K clearance is necessary in order to market the product in the US. The clearance requires compliance to the CFR, Part 820 Quality System Regulations (QSRs), Good Manufacturing Practices (GMP) and the other applicable CFRs for the product type and indications for use. CALISO can assist in the preparation and filing the 510K clearance application, provide training on the GMPs, and the implementation of a quality management system in compliance with the QSRs and applicable CFRs.
NOTE: Registrars and notified bodies sometimes offer a different service called "FDA 510k Reviews". This service is limited to a review of the final draft of the submittal to the FDA. They in NO WAY are allowed to assist or advise you on the how to prepare your submittal, nor provide training or consulting. Our services include assistance in establishing AND final review of the 510k submittal, along with any training or implementation consulting that may be necessary.Here are some important facts about this process:
1/ Establishments involved in the production and distribution of medical devices intended for marketing or leasing (commercial distribution) in the United States (U.S.) are required to register with the FDA. This process is known as establishment registration. Registration provides FDA with the location of medical device manufacturing facilities and importers. A registration fee is under consideration by Congress.
2/ A 510k is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device.
3/ A 510k requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is at least as safe and effective as the predicate.
4/ The holder of a 510k must have design control documentation available for FDA review during a site inspection. In addition, any changes to the device specifications or manufacturing processes must be made in accordance with the Quality System regulation (21 CFR 820) and may be subject to a new 510k.
5/ Please note that the FDA does not perform 510k pre-clearance facility inspections. The submitter may market the device immediately after 510k clearance is granted. The manufacturer should be prepared for an FDA quality system (21 CFR 820) inspection at any time after 510k
6/ The SE determination is usually made within 90 days and is made based on the information submitted by the submitter.
7/ The FDA charges a one-time fee to review your 510k application. This FDA fee was$4,158 through September 30, 2007. There is a discount available to US companies with under $100,000,000 in sales.
Click on the link button below to fill-in information about your product and request a proposal or additional information:
Among the companies we helped in their certification and compliance projects:
The European
Medical Device Directive (MDD):
The European medical device directive makes it mandatory as of 06/28/1998 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.
Medical Device classification in a nut shell (see
93/42/EEC):
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 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 9001/EN 46001 certification.
- 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.
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:
For more detailed information on Medical Devices consult The Bookstore
Medical Device useful links:
Links to European Harmonized Standards (MDD)
Medical Device Directive -93/42/EEC- (MDD)
In Vitro Medical Device Directive -98/79/EEC- (IVDD)
Active Implants Medical Device Directive -90/385/EEC-
(AIMD)
Other useful European Union Links:
Eucomed (European
Confederation of Medical Devices Associations )
BfArM Federal
Institute for Drugs and Medical Devices
Heads of Regulatory
Agencies in the EU
DIMDI-Deutsches
Institut für Medizinische Dokumentation und Information
European
Information System Medical Devices (EUDAMED)
