It is critical to understand all the requirements that your product needs to comply with from the earliest stages of a new product launch or when you are buying medical supplies from an unknown vendor.
We help investors, technology buyers or product developers taking the right decisions from the beginning .
Production. Quality. Compliance. Product Safety.
CE marking is mandatory, allowing your technology to be placed on the market in any European Union member state. There are procedural steps for CE marking, such as fulfillment of technical conditions and requirements for safety and functionality.
ISO 13485 for Quality Management Systems and ISO 14971 for Risk Management are harmonised standards aligned with European regulatory and product safety requirements. A robust implementation throughout your product lifecycle is the strategy to follow in order to achieve compliance.
Post Market Surveillance is mandatory throughout the product lifecycle with outputs to Quality and Risk Management Systems. European MDR requires PostMarket Surveillance documentation records to be submitted.
Technical Conformity reviews of products, systems and documents. Regulatory expertise assessment for compliance with EU current regulatory requirements, MDR and IVDR requirements.
Instructions for Use (IFU), Labelling and Packaging requirements are key elements in product regulatory compliance and they are subject to specific country regulations.
It is mandatory to conduct audits at planned intervals. Auditing is a systematic, independent and documented process for obtaining evidence to determine the extent to which the Medical Devices Quality Systems and Regulatory requirements are fulfilled.
A PMA application involves many volumes of material to be submitted to FDA. The volumes include device description and intended use, nonclinical and clinical studies, case report forms, manufacturing methods, labeling, etc. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of medical devices. PMA requirements apply to Class III devices, the most stringent regulatory category for medical devices.
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims.
All manufacturers (including specification developers) of Class II and III devices and select Class I devices are required to follow design controls (21 CFR 820.30) during the development of their device. The holder of a 510(k) must have design control documentation available for FDA review during a site inspection. In addition, any changes to the device specifications or manufacturing processes must be made in accordance with the Quality System regulation (21 CFR 820) and may be subject to a new 510(k).
Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part.
Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations.
FDA develops and administers regulations under authority granted by laws passed by Congress tLabeling regulations pertaining to medical devices are found in the following Parts of Title 21 of the Code o f Federal Regulations (CFR).
General Device Labeling - 21 CFR Part 80
Use of Symbols - 21 CFR Part 801.15
In Vitro Diagnostic Products - 21 CFR Part 809
Investigational Device Exemptions - 21 CFR Part 812
Unique Device Identification - 21CFR Part 830
Good Manufacturing Practices - 21 CFR Part 820
General Electronic Products - 21 CFR Part 1010