Product Testing – complex, time consuming
and expensive

There are literally hundreds of different requirements and dozens of ways that test can be undertaken. Every day, Horizon Phoenix experts work with clients providing clarity and insight on using testing laboratories, notified bodies, clinical investigators, research facilities and other outside experts.

There are dozens of important questions to answer such as:

  • Can you test in house?
  • Must you use an outside laboratory?
  • At what point in the design, R&D or manufacturing process are tests conducted?
  • How frequently do you test?
  • What sampling plan is used?
  • How are adverse results addressed?

There are literally hundreds of different requirements: International Standards, Parallel Standards, Recognized Standards, Harmonized Standards and each usually has National Deviations. There are hundreds of test laboratories eager to sell you their services and hundreds of jurisdictions that may or may not accept your test results. Not to mention the myriad of test processes you can choose from: Accreditation, Type Testing, Self Certification, Sticker Programs, Design Dossier reviews, product registration with more options being offered every day.

Can you:

  • Justify the testing methodology you selected?
  • Is the laboratory you use appropriately accredited?
  • Do you need a contract with your laboratory?
  • What happens when adverse results are encountered?
  • Do the testing results satisfy your regulatory obligations?
  • How do you defend your decision when challenged by regulators, investigators, owners or shareholders?     (Ask us how…)

The lists and the options that go with them present you with hundreds of seemingly good choices, but which choice achieves all your market access needs and will not shatter your budget? If you test against the wrong requirement you could spend thousands of dollars over six months and literally achieve nothing. Which is right for you? The answer depends on the utility you want from your test results and the jurisdictions where you wish to offer your product for sale. Horizon Phoenix experts successfully negotiate the product testing maze on a daily basis keeping our clients tightly focused on regulatory compliance, budgets and timelines. We can do the same for you… ask us how!

Do not waste time and money conducting testing that does not meet your needs.

Our 37 partners, located around the world, can help you select the right services, from the right people. In fact many times Horizon Phoenix can bundle requirements and through a competitive bidding process not only save you time and money but also make the quality/regulatory process a good deal easier to manage. We always act as mentors to your staff so that the knowledge and expertise resides in your company.

 

Ask us how…

 

Why Horizon Phoenix?

More than 600 companies have benefited from our approach - we do more than simply fulfill regulatory obligations. We will help you gain greater market access, build your customers' confidence and loyalty; brickwall your competition; create an environment for continuous improvement and provide you with competitive advantages.

Our experienced Horizon Phoenix experts have more than 400 years of combined experience in National, Regional, and International product Standards, Good Manufacturing Practices, quality systems, research development, clinical trial management and CE Marking.

At Horizon Phoenix we make your goals our own and then provide innovative solutions to your challenges so that you may achieve your goals on time and under budget.

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