Resources

What is FDA 510k Pre Submission A FDA Pre Submission is a formal written request from a submitter for feedback from FDA that is provided in the form of either formal written response or, if the submitter chooses, formal written feedback followed by a meeting. Such a Pre Submission meeting can be in-person or by teleconference as the submitter prefers. A FDA Pre Submission provides the opportunity for a [...]

Biocompatibility of Medical Devices Biocompatibility testing is a critical part of the regulatory approval process for medical devices as even the best-designed products could produce unintended complications if the materials used, cause a biological reaction in the patient. An integral part of biological risk assessment, biocompatibility testing assesses the compatibility of medical devices with the biological system. It studies the interaction between the device and the various types [...]

Medical Device Shelf life Shelf-life is the length of time you can expect a product to look and act as expected and to stay safe for use. This length of time varies, depending on the type of product, how it is used, and how it is stored. Medical devices containing highly sophisticated electronics that are lasting longer than before, raising the bar for safety and liability. The concept of shelf-life/expiration [...]

Medical Device Sterilization Most surgical and medical devices used in healthcare facilities are made of materials that are heat stable and therefore undergo heat, primarily steam, sterilization. Medical devices that have contact with sterile body tissues or fluids are considered critical items. These items should be sterile when used because any microbial contamination could result in disease transmission. Such items include surgical instruments, biopsy forceps, and implanted medical [...]

Literature Search and Review Protocol Clinical Evaluation Report with incomplete documentation of the literature search and review will lead to a non-conformity. Because the MDCG document 2020-13 specifically requires notified bodies to verify the literature search documentation, this can result in unnecessary questions or even audit variations. A search methodology is used to carry out a literature search and review protocol and other data retrieval. The search protocol [...]

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 [...]

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 [...]

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 [...]

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 [...]

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 [...]

CE Marking Consultants for Medical Device CE Marking Consultants assist new medical device manufacturers in bringing a new device to the EU market or transitioning an existing medical device Technical File to MDR. See how we can assist you in the sections below. The medical device industry is aware of the difficulties in obtaining CE Marking for in vitro diagnostics and medical devices. The new medical device regulation [...]

The major difference 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 [...]

State Of The Art [SOTA / SOA] Clinical Evaluation Report (CER) State of the Art is demonstrated by the inclusion of information related to the standard of care, current knowledge, and available treatment options in the form of devices under evaluation, similar devices, and alternatives of the medical field. During the literature search, a SOTA-specific question is framed, followed by a search using various keywords, and the PICO [...]

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 [...]

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 [...]

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 [...]

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 [...]

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. [...]

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 [...]

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 [...]

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 [...]

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 [...]

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, [...]

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 [...]

CE Certification of NOSE CLEANER under Regulation EU 2017/745 NOSE CLEANER (Regulation (EU) 2017/745) Class: Class IIa, Rule 5: Invasive device: All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to a Class IIa, Class IIb or Class III active device, are classified as class IIa NOSE CLEANER Capsules Class IIa, Rule 21: Devices that are composed of substances or of combinations [...]