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Medical Device Consultancy

Offering expert support in regulatory and clinical documentation helping manufacturers bring safe, effective and compliant products to market.

Explore our Services

Medical Device Consultancy

Offering expert support in regulatory and clinical documentation helping manufacturers bring safe, effective and compliant products to market.

Explore our Services

Medical Device Consultancy

Offering expert support in regulatory and clinical documentation helping manufacturers bring safe, effective and compliant products to market.

Explore our Services

At Clinera Solutions, we offer specialised services in clinical consulting, medical writing, documentation support and bespoke training for medical device manufacturers to achieve compliance with global regulatory requirements, with a focus on EU MDR/IVDR.

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Our Areas of Expertise

Wound Care

  • Wound dressings
  • Antimicrobial wound dressings
  • Wound probe
  • Compression

Surgical

  • Cell concentration
  • Extracorporeal filtration systems
  • Surgical gloves
  • Surgical adhesive
  • Surgical aspiration
  • ECMO coatings
  • Laparoscopic surgical instruments
  • Ophthalmic surgical instruments
  • Preparation of bone marrow concentrate

Software (SaMD)

  • Alzheimer’s detection
  • Data analysis engine

Vascular

  • Vascular catheter
  • Cardiovascular patch

Imaging

  • Ultrasound
  • Intraoperative MRI system

Dental

  • Prosthetics
  • Dentifrice
  • Clear teeth aligners

Disinfectants

  • Medical device disinfectants
  • Hospital surface disinfectants

Orthopaedic

  • Implant
  • Bone cement

In Vitro

  • Fertilisation catheter
  • Intrauterine catheter
  • Lateral flow test
  • ICI fertility treatment

Other

  • Radial shock therapy
  • Throat sprays
  • Inhalation delivery system

What our customers say

  • The outcome of our collaboration was truly exceptional. Ana's dedication and expertise ensured that the project was delivered efficiently and to a high standard, benefiting all stakeholders involved. I would highly recommend Ana for any project requiring regulatory expertise, medical writing, and strong communication skills.
    Andrew Kerr
    Director | Clinical Nurse Specialist
    Lower Limb Consultancy Services
  • Ana has played a key role in shaping strategies that have enhanced the efficiency and compliance of our processes. Under her direction, the Medical Affairs team has successfully launched templates for CER, SSCP, and SOAR files, significantly streamlining documentation processes and improving standardization across workstreams.
    Andrea Piscopo
    Senior Project Manager | Medical Affairs
    ClinChoice

Ready to bring safe, effective, and compliant products to market?

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