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Author is an expert in Medical Device Regulations.

Cleanroom Classification

2021-09-15T04:52:29+00:00

Cleanroom Classification A clean room is an environment, typically used in manufacturing or scientific research that has a low level of environmental pollutants such as dust, airborne microbes, aerosol particles and chemical vapors. More accurately, a clean room has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size. Clean rooms can be very large. Entire manufacturing facilities can be contained within a clean room with factory floors covering thousands of square meters. They are used extensively in semiconductor manufacturing, biotechnology, the life sciences and other fields that [...]

Cleanroom Classification2021-09-15T04:52:29+00:00

Notified Body

2021-06-29T09:07:16+00:00

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 [...]

Notified Body2021-06-29T09:07:16+00:00

Conformity Assessment

2021-06-29T09:03:22+00:00

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 [...]

Conformity Assessment2021-06-29T09:03:22+00:00

Unique Identification Number (UDI)

2021-06-29T09:07:13+00:00

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 [...]

Unique Identification Number (UDI)2021-06-29T09:07:13+00:00

Vigilance Control System

2021-06-29T09:08:20+00:00

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 [...]

Vigilance Control System2021-06-29T09:08:20+00:00

Clinical Evaluation Report Sample

2021-06-29T09:08:51+00:00

Clinical Evaluation Report Sample Follow your instincts A clinical evaluation report shall be compiled to document the clinical evaluation and its output on a specified time schedule. The clinical evaluation report should contain sufficient information to be read and understood by an independent party like regulatory authority or notified body. Therefore, it should provide sufficient detail for understanding the search criteria adopted by the evaluators, data that are available, all assumptions made and all conclusions reached. The Organization must follow following step while doing documentation of clinical evaluation report ( for education and understanding purpose only). Clinical Evaluation Report Sample (CER [...]

Clinical Evaluation Report Sample2021-06-29T09:08:51+00:00

Clinical Evaluation Procedure

2021-06-29T09:09:13+00:00

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 [...]

Clinical Evaluation Procedure2021-06-29T09:09:13+00:00

Demonstration of Equivalence

2021-06-29T09:09:32+00:00

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 [...]

Demonstration of Equivalence2021-06-29T09:09:32+00:00

Clean Room Standards

2021-06-29T09:10:42+00:00

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 [...]

Clean Room Standards2021-06-29T09:10:42+00:00

Stem Cell Consultants

2021-06-29T09:11:23+00:00

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 [...]

Stem Cell Consultants2021-06-29T09:11:23+00:00

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