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.

We simplify MDR and FDA compliance and ensure your products stay aligned with evolving standards

Clinera Solutions make compliance simple for you across any regulatory framework, with an emphasis on MDR and FDA, whilst incorporating MDCG, MEDDEV and ISO.

Ana ensures that you align with evolving standards by providing insight into your current or new documentation without overcomplicating the process.

We know where the difficulties arise when navigating the complex regulatory landscape so our expertise can guide you through them to bring safe, compliant products to market.

We provide transparent, practical and responsive support where it matters most

Our approach is practical and focused, delivering what you need, when you need it. As your additional dedicated point of contact, Liam understands your business and responds quickly when it matters most.

We prioritise clear communication and dependable support, helping you stay on track even under the pressure of tight timelines.

We bring trust and experience grounded in healthcare, regulatory and quality expertise

As a 15-year-long husband-and-wife team from England and Portugal, we reflect a long-standing tradition of collaboration that bring trust, consistency, and care into every client relationship.

With backgrounds in healthcare and personal experience of the impact that medical devices have, we understand what is at stake. Together, we bring over a decade of experience each, combining regulatory and quality expertise with strong B2B relationship management to support your success.

Therapeutic Areas

We've already supported manufacturers in the following:

Wound Care
Surgical
Software (SaMD)
Vascular
Imaging
Dental
Disinfectants
Orthopaedic
in Vitro

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
  • Ana has an excellent eye for detail and a knack for building positive relationships with colleagues as well as clients. She is focused and understands how important her work is in driving innovations in healthcare forward.
    Nehl Karim
    Consultant
    IQVIA
  • As I was growing to learn the industry, Ana was on hand to answer my many, many questions. [...] Aside from her obvious expertise, her flexibility, people skills, and understanding nature means that I would highly recommend working with/for Ana.
    Jacob Tyson
    Consultant
    iMED
  • Ana is great at what she does. She’s a team player and a great support to have in the team. Ana regularly meets time pressured deadlines and was always willing to help me with whatever I needed!
    Cindy Rajaratnam
    Regulatory Affairs Executive
    Roche Diagnostics
  • Ana is a skilful medical writer with significant experience, including preparation of CERs and PSURs to MDR requirements, supporting various clients in gaining / maintaining regulatory approval for their medical devices.
    Stewart Richmond, PhD
    Freelance Consultant
    Nordlys Clinical
  • Ana is a specialist in her field, contributing significantly to the success of the business. Ana is an ambitious and independent expert, with very strong scientific knowledge. I am always able to go to Ana if i need anything to do with sterilisation or sterility of medical products.
    Cole Langham
    Regulatory Affairs Specialist
    ConvaTec
  • Ana has a fantastic work ethic, she is analytical, scientific, [with a] pragmatic approach and a great problem solver. I would happily recommend Ana, and really enjoy working with her. She has a natural flair for taking the ISO standards, and being able to communicate that in a easy to understand manner. Ana writes highly technical documentation and has implemented many successful systems.
    Charmaine Scott-Hibbert
    Managing Director
    Adaptive Device Solutions Ltd.

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

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