Product Certification

Absolute Solutions' mission is to provide a complete business service aimed at assuring the product conformity. We help worldwide exporters to gain global market access. Our extensive experience & structured way of working assures that no stone is left unturned to make your product a global success.

CE Mark is the gateway for the companies who want to export to Europe. The European community has implemented a system to protect the health of consumers and user of manufactured products. CE Mark assures the user of a product that it conforms to the requirements of relevant directive of European union and harmonized European standard. The License is granted by agencies notified by European union.

The 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, Ultrasound devices, External ECGs, Diagnosis devices.

Class IIb :

• Lasers Devices for application, Internal ECGs, RF Generators, Non-energized implants, Treatment devices.

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.

Class IIa & IIb :

• Hold a Technical file* Obtain ISO 9001/ISO 13485 certification.
• Audit by notified body according to Annex II. Apply CE mark.

Class III :

• Hold a Technical file* Obtain ISO 9001/ISO 13485 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 and the label and instructions for use.

The services we offer :
The services will be performed according to GMP/QSR and ISO/EN requirements and include 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.
• Arrange representative in the EC.
• Assist in Vigilance reporting.
• Assist in registration of distributed products with competent authorities in each EC country.
• Customer Complaint handling in EC.
• 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.

The Bureau of Indian standards operates a product certification scheme. The certification allows the licensees to use the popular ISI Mark, which has become synonymous with quality product for the Indian and neighboring markets. ISI Mark assures the user of a product that it conforms to the requirements of relevant Indian standard.

The BIS product certification scheme is essentially voluntary in nature and is largely based on ISO Guide 28 which provides general rules for third party certification system of determining conformity with product standards.

The UL Mark on a product means that UL (UNDERWRITERS LABORATORIES INC.) has tested and evaluated representative samples of that product and determined that they meet UL's requirement

The Canadian standards association is a not-for-profit membership based association serving business, industry, government and consumers in Canada and the global market place.

CSA has published more than 2000 voluntary standards to date in a wide range of subject areas.

FDA 510K Clearance :
For medical devices classified as Class II and 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 manufatcuring Practices (GMP) and the other applicable CFRs for the product type and indications for use. Absolute Solutions can provide training on GMP and assist in the filing the 510K clearance application, and the implementation of a quality management system in compliance with the QSRs and applicable CFRs.

Company Establishment Registration and Device Listing :
Absolute Solutions can also provide assistance in getting your Establishment Registration and Device Listing done for 510K exempt products.

As national economies become global, it's increasingly important that countries work together to facilitate international trade. The CB scheme, established by the International Electro technical committee for Electrical Equipment (IECEE), provides a means for the mutual acceptance of test reports among participating safety certification organization in certain product categories.

The CB scheme is an international network made up of product certification organization in more that 40 countries throughout North and South America, Europe, Asia, Australia. The CB scheme helps you receive international product recognition and national product safety certification.