“Providing Regulatory Solutions & Quality Systems
                            for the Medical Device Industry"
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“I'd like to express my sincere thanks to you for developing and implementing our new ISO 13485 compliant Quality System! I am especially pleased that you delivered the project on time, within budget and with great support for our team at NovaLign. By all accounts, the system fits our needs quite well and does not create an excessive level of bureaucracy.” - J. R. President and CEO “
Results
     Our clients include companies of all sizes, from international corporations to local,
     independent firms.

REGSolutions specializes in creative regulatory strategies and has forged the path for many companies to successfully market their novel technologies. In today’s world of global trade, regulatory strategies must be harmonized to meet all national and international requirements. Regulatory professionals must consider the total product lifecycle for successful entrance of a product to market. Seasoned regulatory professionals are those who are aware of the recent changes at FDA and in the EU MDD and who can react to these changing registration requirements with a successful plan.


We have worked with companies to gain quality management system ISO certifications and CE marking. Our clients are international and local start-up companies, specification developers, and manufacturing corporations. Take a look at some of our recent medical device industries and companies who have been successful with REGSolutions forging the path.


Industries we have recent experience with:

 

  Dental devices
Human and animal tissue medical devices
  Enteral feeding devices
  Medical glue
Obstetric and gynecologic devices
Ophthalmic devices
  Orthopeadic devices
  Surgical gowns and drapes
Urological and gastroenterology medical devices
Vascular access devices

 

References:

Let’s talk today about how REGSolutions can help you.

          Penny Northcutt
                
 RAC, FRAPS, CQA









  678-428-6978
  penny@pennynorthcutt.com