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Author is an expert in Medical Device Regulations.

EU 2017/745 and PMS


EU 2017/745 and Post Market Surveillance EU 2017/745 Post Market Surveillance (PMS) is one of the essential requirements for EU MDR (2017/745) compliance. It refers to monitoring the Medical device after it is introduced into the market and used by public members. Though the conformity of the device to general safety and performance requirements is demonstrated during the premarket phase, at that time it is not always possible to gather all the data related to the safety and performance as some rare complications and risks manifest with the widespread and long term(regular) use of the device. To detect these [...]

EU 2017/745 and PMS2021-11-16T11:07:29+00:00

Investigational Device


Attributes of Investigational Device Exemption for Clinical Studies IDE permits the investigational device to be used in a clinical study in order to assemble data related to safety and efficacy. In order to support PMA clinical studies are conducted whereas as in the case of 510(k)s  rarely clinical data is needed for the application. Clinical evaluation of specific modifications or new intended use of legally marketed devices is to be incorporated for investigational use. Before the clinical study is initiated all the possible clinical evaluations of investigational devices, unless exempt, must have an approved IDE. Perhaps, IDE is considered [...]

Investigational Device2021-11-16T10:10:19+00:00

CE Marking of Teeth Whitening Kit


CE Certification of Teeth Whitening Kit  Teeth Whitner (Regulation (EU) 2017/745) There are two possibilities of Class: Class I, Class IIa, Rule 5 as per Annex VIII Rule 5:  All invasive devices with respect to body orifices, other than surgically invasive devices, which are not intended for connection to an active device or which are intended for connection to a class I active device are classified as Class I if they are used in the oral cavity as far as the pharynx, in an ear canal up to the eardrum or in the nasal cavity for short term use. Class [...]

CE Marking of Teeth Whitening Kit2021-10-28T17:57:29+00:00

Benefit Risk Analysis


Benefit Risk Analysis There is a saying, "A bitter pill to swallow", which means that we have to accept it even though it is very unpleasant. Similar way, the products which we are used for the treatment of patients have some side effects or harm, but we should use them to save lives. Then how can we proceed further? Let's come to know that there is a probability of occurrence of harm associated with the use of particular medicine or device. We should estimate the severity of that harm. We generally called it "Risk". There are different levels of [...]

Benefit Risk Analysis2021-10-27T03:53:04+00:00

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

State Of The Art


State Of The Art [SOTA / SOA] Clinical Evaluation Report (CER) State of the Art is demonstrated by inclusion of information related to the standard of care, current knowledge and available treatment options in form of device under evaluation, similar devices and alternatives of the medical field. During the literature search, SOTA specific question is framed, followed by search using various keywords and PICO strategy and report is prepared accordingly. How to satisfy the requirements for SOTA? By inclusion of below points in CER Clinical background (patient population, medical indication etc) Treatment alternatives available to medical conditions Benchmark devices Current [...]

State Of The Art2021-10-18T05:44:26+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

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