DIA Boston Conference Participants: click here to download the presentation slides and bonus materials

Your Medical
Systems Program.
Done.

Worried about your Quality Systems IT Infrastructure or Medical Device / Drug Development Program? Whatever the reason (technical, regulatory, cost, or due date) -- we have your answer.

To find out more, send us an e-mail at info@priusmedical.com - and start enjoying the benefits right away!

As a "one-stop shop" aggregator of compliance-related R&D and IT Systems Infrastructure services in the pharma / medical device space, Prius Medical Systems can address any product or system development & validation need (including your overall Quality System), however broad or specific, you might have - aside for the clinical or scientific content itself, of course.

And should you choose to employ our proprietary OnTrack^SM program management methodology, you will get unparallelled visibility into cost and schedule expected outcomes, even in the earlier phases of your program, so you can plan your spend levels and product launches optimally and with pinpoint accuracy.

Whether it's compliance-related activities such as systems or software verification, requirements management, documentation and clinical trials management, manufacturing, service, customer support, or technical product development, it is key that you identify trustworthy suppliers that can give you more than low cost.

To be compliant with FDA regulations -- and to stay successful over the long run -- you need consistency and control, and that can only be accomplished via long-term supplier relationships. We stand behind our services and we're here to be with you all the way.

Following is a quick synopsis of the "turn-key" solutions we provide through our consultants and business partners (includes advisory, auditing, training, staff augmentation, and outsourcing services as needed):

Before commercialization:

• Quality systems procedural review and remediation to avoid later FDA compliance issues in audits (GxP, QSR, CAPA, MDR / MDD, Management Review, etc.)
• Clinical trials planning, budgeting, CRO selection and contract management, NDA, IND, and IRB submissions, interfacing with the CDER / CBER / CDRH, etc.
• IT Infrastructure planning, deployment, and validation (internal or third-party hosted), vendor selection, contract management, etc.

After commercialization:

• Planning and implementing corrective action in response to FDA 483s, Warning Letters, operating under Consent Decree, etc. in areas such product design, marketing / labeling, manufacturing, distribution, service, complaints, corrections and removals, CAPA, MDR / MDD reporting, etc.
• Specialized compliance activities such as Root Cause and Health Hazard analyses, FMEA, change management, system safety analyses.
• FDA Audit preparation and training, in-audit advisory, post-audit findings response planning, support with FDAAA clinical trial registry, post-approval studies, Risk Evaluation and Mitigation Strategy (REMS), etc.

"A joke in Chicago, you know, is a riddle in Paris"   - Mark Twain

As a "turnkey" professional organization, we will help you on four important fronts to do offshoring right:

• We will work with you to determine the areas that are strategically best suited for offshoring in your particular case or situation - as driven by your high level business objectives.
• We will evaluate and identify the best offshore partner candidates for you from a pool of carefully prescreened and preselected offshoring firms with proven capabilities in your specific area of need - known to us personally to have succeeded in past engagements similar to yours. Most of them will be specialized divisions of solid, well-known, publicly-traded companies.
• We will closely monitor and help you control the engagement on a day-to-day basis to ensure outcome fidelity and budget / schedule predictability for the entire duration - and avoid the hidden pitfalls and traps so common in offshoring.
• You will benefit from leveraging our extensive large company medical device / pharma expertise in all important areas of FDA compliance (design and document control / RHA / V&V / GLP / manufacturing / service / CAPA / Product Survelillance / 510(k) / clinical trials / PMA / remedial action responding to 483s, warning letters, or operating under a consent decree.)

You get the best of both worlds: the high competence and sophistication of Fortune 100 to audit-proof your operations and the cost savings of offshoring - a powerful winning combination that will put you in the lead. Contact us today at info@priusmedical.com - you'll be glad you did!