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California ISO 13485 Consulting

Affordable Onsite ISO 13485 Consulting and Training for Southern and Northern California Organizations

ISO 13485:2016 is basically ISO 9001 adapted to meet the needs of the medical device industry and satisfy most FDA requirements (Quality Systems requirements - 21 CFR 820). ISO 13485, however, is focused on ensuring medical device safety and efficacy rather than enhancing customer satisfaction and continual improvement. In short, ISO 13485 focuses more on how procedures regulate and control activity as well as process performance.

If your company is already ISO 9001 certified and branching into the medical device industry, we can help you to quickly become ISO 13485 certified.

Affordable ISO 13485 California consulting.

Typical ISO 13485 Benefits

Satisfaction guaranteed!

Improved quality and operational efficiencies, resulting in cost reductions and enhanced bottom-line profitably. Studies have shown that a break-even on your investment in ISO 9001 certification will be achieved within a relatively short period of time.

Entree to foreign markets where ISO 13485 registration is a requirement. Enhanced market appeal and competitiveness when supplying components to medical device manufacturers.

Enhanced customer satisfaction and a more agile, competitive organization. Adds value to company worth.

Easier to comply with regulatory requirements, such as FDA GMP and 21 CFR 820. Reduced worker comp claims.

The ISO 13485 Quality Consultants Turnkey Solution

We offer an affordable turnkey ISO 13485 certification solution to northern and southern California businesses and organizations, consisting of:

Affordable California ISO Consulting

Performing a GAP Analysis to determine the amount of work required to become ISO 13485 certified.

Management orientation to achieve company buy-in and support.

Onsite training to minimize the impact on daily operations.

Templates for creating your ISO 13485 quality manual, procedures and work instructions.

Onsite assistance by an ISO 13485 expert in preparation of your unique quality manual and quality management system.

Internal audit to prepare for a certification audit by an ISO Registrar.

Rapid onsite assistance in responding to any non-conformances identified in the certification audit.

Ongoing maintenance and support to ensure high-quality and readiness for internal and re-certification audits.

What is Involved in Becoming Certified to the ISO 13485 Standard? What Investment is Required? How Long will It Take?

How can your California business become certified to the ISO 13485 standard? This detailed, FREE report explains the steps involved and provides you with an estimate for consulting, Registrar and auditing fees. It also gives you an idea of the timeframe typically required for a company like yours to achieve ISO 13485 registration.

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Affordable Onsite ISO Consulting within California