Atkinson Biologics

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    • Home Page
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Atkinson Biologics

Atkinson BiologicsAtkinson BiologicsAtkinson Biologics
  • Home Page
  • Consultant Services
  • Contact
  • About
  • Project Examples
  • Publications

Atkinson Biologics Consulting

Atkinson Biologics ConsultingAtkinson Biologics ConsultingAtkinson Biologics Consulting

specialization

Biologics

Orthopedic/ spine hardware

Orthopedic/ spine hardware

 Bone grafts, wound covers or dressings, cellular therapies, recombinant proteins, human tissue, peptides and biomaterials

Orthopedic/ spine hardware

Orthopedic/ spine hardware

Orthopedic/ spine hardware

Fusion, fixation and arthropolasty (hip, knee, spine)


 

core competencies

Product Development

Clinical Support and Publication

Clinical Support and Publication

For bone grafts, wound healing, spine fusion, foot and ankle fusion, fracture repair,  sports medicine, osteoarthritis, and cartilage repair.

Biomaterials (collagen, hydroxyapatite, hyaluronate), cellular therapies, human tissue, recombinant proteins, and peptides.

25+ years experience

Clinical Support and Publication

Clinical Support and Publication

Clinical Support and Publication

 Postmarket support from study design/protocol writing through data analysis and manuscript writing.

Protocol writing and strategy for IDE and IND submissions. 

12+ years experience

Clinical Evaluation Report Assistance for Medical Device Regulations

Clinical Evaluation Report Assistance for Medical Device Regulations

Clinical Evaluation Report Assistance for Medical Device Regulations

Write all parts of CER.

Senior review for MDR compliance and quality.

8+ years experience 

 

Regulatory

Clinical Evaluation Report Assistance for Medical Device Regulations

Clinical Evaluation Report Assistance for Medical Device Regulations

PreSub, 510(k), IDE, IND, HCT/P Section 361, Master File, CTD, and combination products.

Regulatory strategy.

25+ years experience 

 

Atkinson Biologics

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