Medical Device Consultancy

Helping manufacturers maintain compliant, evidence-driven medical devices throughout their entire lifecycle.

Explore our Services

Medical Device Consultancy

Helping manufacturers maintain compliant, evidence-driven medical devices throughout their entire lifecycle.

Explore our Services

Medical Device Consultancy

Helping manufacturers maintain compliant, evidence-driven medical devices throughout their entire lifecycle.

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.

Learn More

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

Our Services

Medical Writing

Clinical documentation demonstrates that a medical device is safe, effective, and performs as intended. It’s one of the core pillars of MDR and IVDR compliance, serving as the primary evidence manufacturers must provide to support CE marking and maintain market approval.

Post Market Surveillance

Post-market surveillance (PMS) is the continuous monitoring of a device’s performance and safety once it’s on the market. It’s a legal requirement under MDR Annex III, designed to ensure manufacturers remain responsible for their products throughout the entire lifecycle.

Risk Management

Risk management is the framework that keeps patients safe and products defensible. Under ISO 14971:2019 and MDR Annex I, manufacturers must identify, evaluate, control, and monitor risks throughout a device’s entire lifecycle.

Regulatory/Strategic Consulting

Regulatory strategy defines the path your device will take to market and how efficiently it gets there. We provide tailored guidance for medical device manufacturers navigating MDR, IVDR, and UKCA frameworks, helping you interpret evolving requirements and make proactive compliance decisions.

Templates, Tools, Training

True compliance depends on more than just documentation. We help organisations build internal competence through bespoke tools, templates, and training tailored to their workflows, device types, and regulatory maturity.

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?

Book a Consultation

Medical Device Consultancy

Medical Device Consultancy

Medical Device Consultancy