ISO 13485 Certification assists Medical Device related Organisations in achieving their aims & improving their business by helping them to manage & improve (rather than fire-fight). For CE Mark of Medical Device/s, the business will require ISO 13485 Certification.
Contact us today to also benefit from ISO 13485 certification and accreditation with increased operational efficiency. The requirements are well tested and help improve operations, productivity and profitability.
Click the following links for more specific information:
ISO 13485 is the Quality Management Standard for Medical Devices. It is required for the CE Mark of Medical Devices. Additionally it is not the only way of improving Quality. Over the last 100 years, there have been many different initiatives. Regrettably they have generally suffered from being:
ISO 13485 addresses each of these limitations.
Organisations, to achieve ISO 13485 Certification, must be committed to a focused and systematic approach to business with fact based decision making. They should be able to demonstrate both internally and to the external Assessor:
Additionally any ISO 13485 Quality system needs to be flexible, so assisting the business to succeed in today’s volatile and competitive environment. For instance your hosted Per4ma Business Model enables immediate online editing to ensure everyone is working from the latest Documents and Forms, whether they are working inside or externally to the Company.
The evidence is that implementation costs are an investment with the return of cost advantages and other improvements gained by better methods, improved productivity, reduction of waste and better management control. Achieving successful Assessment and Certification also assists in retaining existing Customers and in gaining new Customers.
For CE Marking of Medical Devices and to invest in your business
The quick answer is contact us, but there are common steps
Three Format Options for your manual, documents, forms, process diagrams/ procedures and forms:
Contact us today for the first steps to ISO 13485 Certification
Invest in your future by improving your Business. We have options to suit your situation including
Call us: (0)1635 595123
Email us: firstname.lastname@example.org
For a free discussion or quote or for further information about this certification standard.