Aequitas Consulting was established to aid small medical device companies in achieving and maintaining compliance, specifically with ISO13485 Quality Management Systems and compilation of CE marking technical documentation (Class 1 – class IIa). I can also assist with Sterilization Validations as well as operational streamlining within the business wrt to processes. I also have experience with in country registrations of medical devices. By joining this group I hope to expand my network and assist small med tech tech companies with regulatory compliance.
| Qualifications | BSc Molecular Biology and Biotechnology |
| Specialist areas: | Disposables, consumables, general medical devices Manufacturing Quality Assurance (GMP or ISO13485) Regulatory / Legal |
| Contact Details: | odette@aequitasconsult.com 082 847 4183 |