FDA 510k Pre-Submission and Q-Submission Pre or Q 510k Submission permits the manufacturer/applicant to request formal feedback on FDA 510k files precise to (a) test Protocols, (b) good sized Equivalence, (c) missing phase, and many others. It allows the manufacturer/applicant to request formal feedback on the documents of your scientific device, particularly on (a) takeContinue reading “FDA 510k Submission for medical device”
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Dealing with CE Marking Problems & Issues
Rules and conditions for applying the CE marking – The CE marking must be applied to the product or its data plate in a visible, legible, and indelible manner. If this is not practicable or warranted due to the nature of the product, it must be affixed to the package as well as the supportingContinue reading “Dealing with CE Marking Problems & Issues”
The Right Agency For ISO 13485 Certification
ISO 13485 certification for medical devices is an excellent quality management system required for regulatory functions that’s an ISO standard, it represents the necessities for a whole best control device for the design and production of medical devices. Regulatory necessities are more and more stringent during each step of a product’s lifecycle, along with services andContinue reading “The Right Agency For ISO 13485 Certification”
Medical Device Security Challenges and solution
Medical tool businesses have been able to expand devices that offer better treatments, extra unique diagnoses, increased information reporting talents, and typical higher affected person tracking due to the fact to technological improvements in and round the sector. Many industry professionals are worried approximately the capability protection hazard for medical equipment as cyberattacks grow toContinue reading “Medical Device Security Challenges and solution”
Structure a Risk Management File
The growth within the medical device usage has caused growth a complexity of making the medical device secure for human use. threat control process want to set up by the medical device manufacturer to make sure tool protection, usability & regulatory compliance. medical device producer shall set up, put into effect, record and preserve anContinue reading “Structure a Risk Management File”
Blood Collection Tubes Manufacturing
A Blood Collection Tube Manufacturing is of BCT/ Vacutainer which is a sterilized glass or plastic test tube with a coloured rubber stopper which creates a vacuum seal inside the tube supporting the draw of a fixed volume of liquid. It is also referred to as the “Vacutainer”. Vacutainer tubes consist of additives which are designed toContinue reading “Blood Collection Tubes Manufacturing”
ISO standards for medical devices
ISO standards for medical devicesThe international Standardization organization (ISO) is an unbiased, non-governmental company that has created hundreds of international standards for numerous industries, together with medical devices. ISO requirements are voluntary, consensus-primarily based documents that provide steering on particular aspects of generation and production. For medical device producers, ISO requirements are important not handiestContinue reading “ISO standards for medical devices”
CE Drug-Device Combination
Drug-device combination (DDCs) products are therapeutic and diagnostic products that combine medical tool with tablets, and/or biological products. on account that these are claimed to obtain drug concentrated on, it’s far taken into consideration as more secure and more powerful treatments for local management and individualized therapy. Such technologies are termed as boon for sufferers laidContinue reading “CE Drug-Device Combination”
How to Start a business of Durable Medical Equipment
If you are interested to start the Durable Medical Equipment enterprise, let me tell you this is a proper time. medical device business industry is developing hastily .modifications in technology, want of innovation, new guidelines and authorities’ self- reliant technique toward the enterprise are the few supporting factors for the boom. India is dependent for importing medicalContinue reading “How to Start a business of Durable Medical Equipment”
latest Guidance on Borderline Products as per MDR
Definition: Borderline products are ones for which it is unclear whether they come under MDR or MDP from the start. If the product is subject to MDR, it must comply with MD Article 2(1) and must not be within the scope of MDR Article 1(6). thanks to new tips provided by way of the european commission’s medicalContinue reading “latest Guidance on Borderline Products as per MDR”
Medical devices consultancy 