Medical Devices are the highly regulated market and maintaining the appropriate complaint Quality Management system is the responsibility of the Manufacturer of the product. The Quality Management system can be ISO 13485:2016 or implementing 21 CFR Part 820, 21 CFR part 210 and Part 21 or EU GMP is important depending on the product ( Medical device or combination product) and country-specific requirements. When a manufacturer decides to enter a new market, he has to consider not only the regulatory requirements of that particular market but also has to determine how those requirements apply to his product. Depending on the risk class of the product, intended use, the regulatory expectation may vary. For regulatory approvals in the US depending on the class, 510 (k) may be required and in Europe, the product compliance is demonstrated by submitting the technical file, design dossier as applicable to the European authorities.
We Provide Following Regulatory & Certification Services For Medical Device Manufacturers
ISO 13485 Certification Consultant: ISO 13485 is a Quality Management system specifically developed for Medical Devices & related services. The ISO 13485 is worldwide recognized Quality Management system standard to demonstrate the system compliance for designing, Manufacturing and supply of Medical devices depending on the scope of certification.
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
The new ISO 13485:2016 focuses on how companies should manage risk-based decisions related to purchasing, design, development, manufacturing, production control activities and other aspects of the quality management system.
USFDA 510(k) and Establishment registration and Device listing consultant:
In the US, the Products are Classified as Class I, Class II or Class III. Depending on the Class of the Product and Notify of the product the Product can be sold in the US by simply doing Establishment registration and device listing or 510 (k) or by submission of PMA. The Establishment registration is a Necessary Requirement to place your products in the USA. After registration, the manufacturer is allotted a Registration number and device listing number which is used by US Custom Authority & Other concerned Authorization in the USA to Establish your Actual identity as suppliers to the USA. In case of the GMP –Non exempted products, it is manufactured is expected to implement the requirements as laid down in 21 CFR Part 820 and /0r 21 CFR part 210 and 21 CFR Part 211. In case of the 510 (k) non exempted products, the 510 (k) submission shall be done at the CDRH (centre for devices and radiological health) or OCD ( Office of combination devices). The office reviews the file and offers the 510 (k) number to the product depending on the review. After receipt, the 510 (k) number, the establishment registration and device listing shall be done in order to export product to the US.
CE Mark Certification Consultant: In Europe, the products are classified as Class I, Class IIa, Class IIb or Class III. In order to market products in the European market, the products must have a CE mark which declares that a product meets the EC directives. The Manufacturer expecting the CE marking shall is expected to implement the requirements as laid down in ISO 13485. The review of the technical file, design dossier and audit at the site is conducted by the Notified body in order to ensure the compliances. A CE Marking Technical File or Design Dossier (Class III) is a file Containing depiction of your gadget intended to show consistency with European requirements. Compiling your specialized record or plan dossier is a basic advance in Europe’s CE Marking process and a necessity for consistency with the Medical Devices Directive 93/42/EEC, In Vitro Diagnostic Medical Devices Directive 98/79/EC, or Active Implantable Medical Devices Directive 90/385/EEC.