Resources

Notified Body The Governments of the European member states designated some organizations known as Notified Body who are being found competent to make independent judgments about whether or not a Medical Device complies with new Medical Device Regulation (MDR) and Invitro Diagnostic Regulation (IVDR). MDR & IVDR Notified Bodies New EU MDR and IVDR qualification process is going on and more notified Bodeies will be added. Up-to-date information of notification status, NB contact details and scope can be found from MDR qualified Notified Bodies can be found in NANDO database. IVDR qualified Notified Bodies can be found in NANDO database. These Bodies are [...]

Conformity Assessment Conformity assessment (CA) activity is the process describing whether the requirement of the MDR relating to a device have been fulfilled. It is one of the key elements of the existing regulatory approach which would call for high level of safety protection world-wide and would facilitate trade. For all the devices, Annex IX to XI has laid out the conformity assessment procedures which needs to be followed by the manufacturers before placing their devices in the market. Where, Annex IX states about Conformity Assessment Based on A Quality Management System and On Assessment of Technical Documentation. Annex [...]

Unique Identification Number (UDI) The EU MDR mandates the use of a Unique Device Identification (UDI) system which will allow the identification and facilitate the traceability of devices It can be implemented by establishing an electronic system for the Unique Device Identification (UDI Database). Place the UDI on the label of the device or on its packaging Make it appear on the EU Declaration of Conformity. Should keep up-to-date lists of all the UDIs that has been assigned. Register the device - the manufacturer should assign a Basic UDI-DI to the device and shall provide [...]

Vigilance Control System EU MDR Section 2, article 87 mandats for reporting of serious incidents and field safety corrective actions. Thus manufacturers selling medical device in Europe are legally obligated to report any adverse events or incidents or if any recalls in the european terttroy. This process is called as vigilance reporting. Foreign manufactures are thereby advised to coordinate with European authorized representative for vigilance reporting. According the guidance document MEDDEV 2.12/1 vigilance report means Incident Reports and Field Safety Corrective Action (FSCA) reports. Patient death, serious injury, or may lead to death or serious deterioration in state of [...]

Clinical Evaluation Procedure / SOP & Report As per Article 5, section 3 of Placing on the Market and putting into service, the manufacturer must demonstrate the conformity with the general safety and performance requirements of the medical devices and shall include a clinical evaluation in accordance with Article 61. As per article 10, section 3 of General Obligation, the manufacturer shall conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a PMCF. As per article 32, section 2 of Summary of Safety and Clinical Performance, shall summarize safety and [...]

Demonstration of Equivalence. Is a must? MEDDEV 2.7/1 Rev. 4 requirements for demonstrating equivalence is more stringent as it is in MDR. Full demonstration of Clinical, Biological and Technical equivalence with respect to medical device characteristics must be performed during Medical Device Clinical Evaluation. Some key points for manufacturers to consider. As per latest MDR, for a Class III implantable and few Class IIb device manufactures must have a contract with the owner of the equivalent device for granting permission to access the technical documentation of the equivalent device by applicant ‘s Notified Body. Due to this dilemma to have [...]

Clean Room Standards Clean rooms are classified by the cleanliness of their air. The method most easily understood and most universally applied is the Federal Standard 209 of the USA. In this old standard, the number of particles equal to and greater than 0.5 mm is measured in one cubic foot of air and this count used to classify the room. The most recent 209E version has also accepted a metric nomenclature. In the UK, the British Standard 5295, published in 1989, is also used to classify clean rooms. This standard will shortly be superseded by BS EN ISO [...]

Stem Cell Consultants Our Specialized Services Comprehensive Technical and Scientific backup : Stem Cell expansion and differentiation protocols. Device (therapeutic & processing) design, development etc. Designing and developing stem cell processing protocols on the lines of drug discovery and/or toxicity testing. Facilitation of clinical translation from pre-clinical data through IND for cell therapy products. Market research and analysis : We will perform the Introductory overview of regenerative medicine industry, market analysis, market research, development of regenerative medicine / cell therapy strategies for clients, VC`s, Corporate etc. to identify opportunities in stem cell industry. Product Marketing : Our biggest strength lies [...]

Heating Ventilating and Air Conditioning (HVAC) HVAC (pronounced either "H-V-A-C" or "aitch-vak") is an acronym that stands for the closely related functions of "Heating, Ventilating, and Air Conditioning"- the technology of indoor environmental comfort. HVAC system design is a major sub discipline of mechanical engineering, based on the principles of thermodynamics, fluid mechanics, and heat transfer. Refrigeration is sometimes added to the field's abbreviation as HVAC & R or HVACR, or ventilating is dropped as in HACR (such as the designation of HACR-rated circuit breakers). HVAC is particularly important in the design of medium to large industrial and office [...]