Regulatory and Standards Compliance Licensing & Acquisition Global Market Support Risk Management Process Development

Do you have the resources to update your products to the new 60601-1? SDCS offers a Compliance Upgrade Package that includes new or revised documentation including analyses required by the 2005 Edition of 60601-1 and detailed specifications identifying any necessary design changes minimizing the impact to your Engineering resources!

Is compliance with standards and regulation an obstacle or a tool that reduces your time to market? A strategic approach to device compliance will assure that the certification and regulatory approval for your product occurs in the shortest possible time and at the most reasonable cost. Let us help your organization implement a Strategic Compliance Process that will consistently improve your bottom line!

Rapid Access to Global Medical Device Markets and Strategic Partnerships: Our extensive knowledge of regulatory and standards requirements, contacts with regulators and certification bodies around the World can give your organization the edge. Our close work with device manufacturers in most markets can help you find strategic partners and establish alliances in virtually every developed market. AND NOW WE OFFER ACCES TO CHINA!

China UL CSA 601-1 Europe MDD FDA medical device regulation regulatory compliance litigation global standards risk management mike Schmidt 14971 essential performance EMC 60601-1-2 China UL CSA 601-1 Europe MDD FDA medical device regulation regulatory compliance litigation global standards risk management mike Schmidt 14971 essential performance EMC 60601-1-2 China UL CSA 601-1 Europe MDD FDA medical device regulation regulatory compliance litigation global standards risk management mike Schmidt 14971 essential performance EMC 60601-1-2 China UL CSA 601-1 Europe MDD FDA medical device 60601-1-6 Regulation standards risk management mike Schmidt 14971 essential performance EMC 60601-1-2 China UL CSA 601-1 Europe MDD FDA medical device regulation regulatory compliance litigation global standards risk management mike Schmidt 14971 essential performance EMC 60601-1-2 60601-1-6 IEC 60601-1 60601-1-6 training IEC 60601-1 training testing training IEC 60601-1 training usability process usability process usability process usability training third third third 3rd 3rd 3rd edition edition edition 2005 2005 2005 new new new standard standard standard standard

Regulatory and Standards Compliance

Licensing & Acquisition

Global Market Support

Risk Management

Process Development

Are you wasting valuable human and financial resources sending company personnel for training? Typical costs for an single employee to go to a two-day seminar on standards or regulations can include $400-$900 for travel expenses, $800-$1200 for the training and lost productivity. We can offer customized training for any number of employees on-site with content customized for your organization - for as little as $2000! Here are a few comments from individuals who have attended our training:

"...put it into perspective for me."

"...very impressed ... With how he was able to translate knowledge to us!"

"...I actually understand the concepts more."

We can provide higher quality training for a fraction of the cost!

Critical Questions That Affect Your Bottom Line:

> How will the third edition of IEC/EN 60601-1 affect your products?

> What constitutes Essential Performance for your products?

> Is your Risk Management process compliant with ISO 14971?

> What are the impacts of the new 60601-1-2 EMC standard?

> Why is IEC 62336 critical to designing safe devices?

Find the answers to these and other important questions !