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The Halper Group
3305 Beckham Ct.
Plano, TX 75075 USA
Tel: 972/612-0214
Fax: 972/596-7294
Contact: Laura A. Halper, PhD
Year Established: 1989
Web: http://www.TheHalperGroup.com
E-mail: thg@sprintmail.com
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Description:
The Halper Group provides regulatory and quality systems consulting, auditing, and training to help medical device companies enhance business performance while ensuring compliance. Services include implementing QSR/ISO quality systems, assisting with CE-marking and writing 510(k)s, conducting process validations, and advising on responses to FDA-483 warning letters.
Categories this company is listed under in the Consultants Directory on Medical Device Link:
- Audits/Inspections (43 companies)
- Good Manufacturing Practices/Compliance (53 companies)
- ISO 9000 (21 companies)
- Process Validation (32 companies)
- Quality Assurance (47 companies)
- Regulatory Affairs (51 companies)
