Resources2021-09-16T10:38:16+00:00
3007, 2022

Quality in 510(k) Review Program Pilot

By |July 30th, 2022|Categories: Resources|Tags: |

Quality in 510(k) Review Program Pilot Quality in 510k  review program pilot (RPP) gives an different method to submit a 510k to the FDA via the eSubmitter software. ( For specific device types) On April 26, 2021, the FDA announced the decision to conclude the Quality in 510(k) Review Program Pilot. Quality in 510(k) Review Files will no longer be accepted by the FDA after May 30, 2021. [...]

3007, 2022

Medical Device Reporting (MDR)

By |July 30th, 2022|Categories: Resources|Tags: |

Medical Device Reporting (MDR) Medical Device Reporting (MDR) is one of the Postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. Mandatory reporters are manufacturers, device user facilities, and importers. Hence Mandatory reporters are required to submit to the FDA certain types of reports for adverse events and product problems about medical devices. The [...]

3007, 2022

Software Verification and Validation

By |July 30th, 2022|Categories: Resources|Tags: |

Software Verification and Validation Software validation is a requirement of the Quality System regulation. Validation requirements apply to software used as components in medical devices, to software that is itself a medical device, and to software used in the production of the device or in the implementation of the device manufacturer's quality system. Software is frequently purchased off-the-shelf for a particular intended use so, it should have documented [...]

207, 2022

Medical Device Labelling in 510k

By |July 2nd, 2022|Categories: Resources|Tags: |

Medical Device Labelling in 510k Medical Device Labelling in 510k : Label is display of written, printed, or graphic matter upon the container of any article/medical device, it includes details like instructions for proper use, requirements for operating device safely, storage and maintenance and installation requirements, it also includes information that when particular medical device is put up for sale in the market. It must be clearly visible [...]

1106, 2022

Medical Device Shelf life

By |June 11th, 2022|Categories: Resources|

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 [...]

1006, 2022

Medical Device Sterilization

By |June 10th, 2022|Categories: Resources|

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 [...]

1305, 2022

Literature Search and Review Protocol

By |May 13th, 2022|Categories: Resources|

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 [...]

1611, 2021

EU 2017/745 and PMS

By |November 16th, 2021|Categories: Resources|

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 [...]

1611, 2021

Investigational Device

By |November 16th, 2021|Categories: Resources|

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 [...]

2810, 2021

CE Marking of Teeth Whitening Kit

By |October 28th, 2021|Categories: Resources|

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 [...]

2710, 2021

Benefit Risk Analysis

By |October 27th, 2021|Categories: Resources|

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 [...]

1410, 2021

Stem Cell Facility Consultants (GMP)

By |October 14th, 2021|Categories: Resources|Tags: |

Stem Cell Facility Consultants (GMP) We support companies poised to make early inroads into the burgeoning Stem cell & Regenerative Therapy industry to improve their business, profile, products, and processes. Who can benefit from our Stem cell consultancy services? Companies new to the sector (e.g., pharma's, biotech, investor, VC`s, etc.) we help you understand the stem cell industry and opportunities for your participation. Companies who are already in [...]

2906, 2021

510(k) Program Pilots

By |June 29th, 2021|Categories: Resources|

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 [...]

2504, 2021

CE Marking Consultants

By |April 25th, 2021|Categories: Resources|

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 [...]

1904, 2021

Major difference between MDD and MDR

By |April 19th, 2021|Categories: Resources|

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 [...]

1804, 2021

State Of The Art

By |April 18th, 2021|Categories: Resources|

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 [...]

1604, 2021

Heating, Ventilating, and Air Conditioning (HVAC)

By |April 16th, 2021|Categories: Resources|

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 [...]

1604, 2021

Cleanroom Classification

By |April 16th, 2021|Categories: Resources|

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 [...]

1604, 2021

Notified Body

By |April 16th, 2021|Categories: 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 [...]

1604, 2021

Conformity Assessment

By |April 16th, 2021|Categories: Resources|

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 [...]

1604, 2021

Unique Identification Number (UDI)

By |April 16th, 2021|Categories: Resources|

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. [...]

1604, 2021

Vigilance Control System

By |April 16th, 2021|Categories: Resources|

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 [...]

1404, 2021

Clinical Evaluation Report Sample

By |April 14th, 2021|Categories: Resources|

Clinical Evaluation Report Sample 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 [...]

1404, 2021

Clinical Evaluation Procedure

By |April 14th, 2021|Categories: Resources|

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 [...]

803, 2021

Demonstration of Equivalence

By |March 8th, 2021|Categories: Resources|

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 [...]

1411, 2020

Clean Room Standards

By |November 14th, 2020|Categories: Resources|

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 [...]

1410, 2020

Stem Cell Consultants

By |October 14th, 2020|Categories: Resources|

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, [...]

1404, 2020

Heating Ventilating and Air Conditioning

By |April 14th, 2020|Categories: Resources|

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 [...]

1802, 2020

CE Certification of Nasal Cleaner

By |February 18th, 2020|Categories: Resources|

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 [...]

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