Iso 13485 Medical Devices Qms Requirements

Iso 13485 Medical Devices Qms Requirements

Service overview

Progressive Management Services can assist organizations that are seeking to become certified to ISO13485. Progressive Management Services can provide gap analysis/pre-assessments, internal audit service, on-site training, procedure writing, implementation/consulting and other services
ISO 13485
The ISO 13485 standard is for organizations that design and manufacture medical devices and need to demonstrate its ability to provide services and medical devices that constantly meet customer and regulatory requirements. Compliance with ISO 13485 is the first step in achieving compliance with European regulatory requirements. ISO13485 is harmonized with ISO 9001, however medical device regulatory requirements for quality management systems are incorporated into the standard and ISO13485 excludes some of the requirements of ISO 9001 that are not appropriate to the regulatory requirements. Progressive Management Services can help your organization to become ISO 13485 certified with services like procedure writing, internal auditor training, on-site training, gap analysis, consulting and other services.
For ISO 13485, a comprehensive QMS for design and manufacture of medical devices needs to be implemented. Regardless of the type or size of an organization, all requirements of ISO13485 are specific to organizations providing medical devices. Due to the nature of the medical device(s) and service(s) provided, many organizations take exclusion to design and development requirements and other requirement(s) in Clause 7 of ISO13485 by properly documenting justification statements for each exclusion. Additional requirements of ISO13485 include the promotion and awareness of regulatory requirements (21 CFR 820 Quality System Regulation for Medical Devices sold in the United States), risk management, requirements for sterilization, inspection and traceability for implantable devices.
With the help of qualified QMS professionals in our organization, we are able to build and put into practice a Quality Management System that factor in all the aspects of your organization. One can be assured of the ISO 13485 certification after receiving our comprehensive services. Progressive Management Services will work out a viable approach that is best suited for your organization to function in the most productive and effective manner.
Our services for organizations seeking ISO 13485 certification include –
Policy Manual prepared by seasoned experts in the field.
Providing Procedures Manual by the same or similar experts.
Assistance in writing Work Instructions.
On-site assistance for implementing the quality management system.
Gap Analysis
Internal Audits and Auditor Training

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Progressive Management Services is the reputed organization in the realm of providing assistance in obtaining various quality certifications. We are a leading service provider in the field of ISO 9001:2008, ISO 14001:2004, HACCP, ISO /OHSAS 18001:2007, ISO-13485, ISO-22000:2005, ISO-27001:2005, SA-8000, TS-16949, CE Marking, Six Sigma Certification, GMP , BRC, Kosher, HALAL, NABL Documentation, NABH Documentation, CE Marking & other Related Management Certifications to Establish or Promote of Any kind of Business. Our team is like a family, dispersed all over the Globe, which believe in results. The team members are amongst the most experienced and qualified in the industry resulting in the best of out comes; ready to take the latest technologies with a free creative mind. We provide one of the most exhaustive suites of ISO consulting services to help the companies plan, design, implement, monitor, control, improve and enhance their ISO management system. Our ISO consultants are known in the field of management system certification for being innovative, simple, practical and effective resulting in a implementation process that is value adding to the business operations of the organization.. view more »

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