Stem Cell Facility Consultants

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. The applicable medical device codes for this programme were also published by FDA. The Quality in 510(k) Review Program pilot's goal is to assess the program's effectiveness and determine whether using [...]

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 Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA. Manufacturers: Manufacturers [...]

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 requirements that fully define its intended use, to show that the software is validated for its intended use. Device manufacturers may use the same procedures and records for compliance with quality [...]

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 even if they contain is having any additional packaging. Medical labelling must follow instructions listed on FDA CFR 21 Part 801. No false information should be displayed on label. In addition [...]

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 the Stem cell sector, we help you to position the company and/or products better to capture more market share. Mature companies, who eye the attention of potential investigators, collaborators, licensees, partners, [...]