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Author is an expert in Medical Device Regulations.

510(k) Program Pilots


Quality in 510(k) Program Pilots For specific device types, the Quality in 510(k) Review Program Pilot offers an alternative means of submitting a premarket notice (510(k) to the FDA by using the e-Submitter software to prepare the submission. The FDA announced its intention to end the quality in 510(k) review program pilot on april 26, 2021. quality in 510(k) review files will no longer be accepted by the FDA after May 30, 2021. The FDA also provided a list of the medical devices and product codes that were applicable to this programme. The pilot's goal is to assess the [...]

510(k) Program Pilots2021-06-29T09:34:43+00:00

CE Marking Consultants


CE Marking Consultants for Medical Device CE Marking Consultants assist new medical device manufacturers in bringing a new device to the EU market or in transitioning an existing medical device Technical File to MDR. See how we can assist you in the sections below. The medical device industry is now acutely aware of the difficulties in obtaining CE Marking for in vitro diagnostics and medical devices. The new medical device regulation (MDR) and the in-vitro diagnostic regulation (IVDR) both require more and more detailed documentary evidence to show that your device is safe, efficient, and performing as intended by [...]

CE Marking Consultants2021-06-29T08:58:44+00:00

Major difference between MDD and MDR


The major differences between MDR and MDD Red marked are the major differences in the MDR requirements. Term MDR Surgically Invasive Device an invasive device which penetrates inside the body through the surface of the body, including through mucous membranes of body orifices with the aid or in the context of a surgical operation; (Annex VIII) Injured skin or mucous membrane means an area of skin or a mucous membrane presenting a pathological change or change following disease or a wound. Active device Covered under Article 2 ‘active device’ means any device, the operation of which depends on a [...]

Major difference between MDD and MDR2021-09-14T10:16:49+00:00

Heating, Ventilating, and Air Conditioning (HVAC)


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 [...]

Heating, Ventilating, and Air Conditioning (HVAC)2021-06-29T09:03:09+00:00

Cleanroom Classification


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


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


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)


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


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


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

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