INTRANET

Medical Device

From initial idea to compliant production

Aptio Group’s Medical Device services are delivered by senior consultants—many with 20+ years’ experience—who have helped pharma and life science teams bring innovative devices from idea to compliant production.

We have specialist knowledge from assignments across Denmark and Europe and our support spans the full product lifecycle: from product development, manufacturing development (e.g., pilot equipment), process validation and scale-up, to stable, validated production. Thus, we work seamlessly in both CAPEX projects and OPEX environments.

Design Control is the backbone of our approach. We provide practical guidance across device development, quality management and regulatory compliance—turning requirements into clear deliverables and documentation. Our team stays current on EU regulatory expectations so you can move forward with confidence.

If you want a partner who is pragmatic, fast, and to the point, our consultants are ready to help with every aspect of the medical device journey—from concept through validated production and beyond.

Supported areas

Project Management

  • Product Development
  • Product Risk Management
  • 3D Part Design
  • Creative Sessions and Innovation
  • Design for Manufacturing
  • Design Control and Establishment of DHF

Typical consultant expertise

  • Device Project Assistant
  • Project Manager
  • Work Package Owner Assembly
  • Assembly Engineer
  • FAT coordinator
  • Contract Management
  • Validation Engineer
  • Design For Manufacture Engineer

Process

  • Research and Regulatory Services
  • Tolerance Chain Calculation
  • HFE – Human Factor Engineering
  • UE – Usability Engineering
  • Design Verification and Reviews
  • Specification and Test of Equipment (Pilot and Full Scale)
  • Validation and Documentation (Plans, Protocols, Test Plans and Reports)

Typical consultant expertise

  • Device Development Engineer
  • Device Engineer
  • Test Engineer
  • Risk Management Engineer
  • Vision Subject Matter Expert
  • Technical Writer
  • DoE and Statistics

Implementation and certification of Quality Management Systems for start-up and growth companies

We have extensive experience with implementing and improving quality management systems. We not only implement a QMS – we also show you how to use it to ensure compliance. To us, the important part is not only achieving certifications but also anchoring a quality mindset in your business so that you recognize the benefits. 

We always start our journey with our customers by determining your actual needs and ensuring that you only perform work that is necessary. Why implement a gold-plated QMS system if it isn’t needed? 

We are
specialists in eQMS

At Aptio, we believe that eQMS solutions are the right choice for most medical device companies. Our consultants have hands-on experience with implementing different eQMS solutions, such as Greenlight Guru and SimplerQMS. We can help you choose the right solution in the beginning and support you all the way through to the implementation and certification process. Again, our focus is not only certification. Our goal is to be your quality partner so that we can ensure quality and compliance together. 

Contact us now

Peter Roldskov

COO of Aptio Group
VP, Medical Device

Peter has +20 years of experience providing engineering and consultancy services to the pharma, biotech and medical device industries, with a unique ability to bridge technical solutions with commercial and business-related aspects.

He has a broad background in all of the necessary disciplines to ensure the smooth delivery of CAPEX projects and GMP regulated production environments.

Submit your CV

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We have a lot of opportunities to try new jobs and challenge your skills. I feel it’s a really cool place to work and I have the best colleagues and management, and we support each other as a team.

There’s a lot of room to grow and develop your skills and it’s a great opportunity to work on different projects with different clients and try new skills. I know my work contribute to something good and it’s a gift to have experienced colleagues.
People stay long in Aptio Group, the team is amazing as the management, who always support education. It feels very safe to have a team you can rely on and have you back though it’s a business, where you meet a lot of new people and clients.

Sometime people know more than you and I wanted to be part of that kind of network.

Personally I have been growing quite a bit due to the task I have been given, so it’s a great way to develop professional.
We have a very good team and collaboration, where we really get the ball moving and are focused on the end goal. We support each other and the hierarchy is flat so I really appreciate the support from the management team.

Join Aptio Group for the interesting projects, to have fun and be a part of a very good community with a family feeling.

Their strong industry reputation and commitment to technical projects across diverse fields made them the right choice. Additionally, Aptio’s flat organizational structure and extensive network were crucial factors in my decision.  

Working at this well-established consulting firm provides me with valuable growth opportunities both personally and professionally, thanks to their expertise and collaborative environment.  

My expertise in Sourcing, Procurement, and Supply Chain, honed over +20 years from different industries, allows me to contribute effectively to the comprehensive package Aptio offers its clients

Exciting Challenges  

The projects I work on are always stimulating. Management keeps me on my toes with complex tasks that push me to grow and excel. It’s a constant adventure of learning and improvement. 

Fantastic Colleagues  

My colleagues are more than just coworkers; they’re friends. Despite being spread across different locations in Denmark and abroad, we’ve formed a tight-knit group. We enjoy wine tastings, dinners, and company trips that blend work and fun. This camaraderie is all thanks to the way management fosters our connections. 

Support When Needed  

I always feel heard and supported. Management is there for me whenever  

I need guidance or assistance, making me feel valued and understood. 

Freedom to Be Myself 

Aptio gives me the freedom to be myself. There’s room for individuality,  

and I appreciate the trust and autonomy I have in my role. 

Why I chose Pharma Engineering and stay with Aptio Group 
My journey into pharma engineering was fueled by a passion for innovation and contributing to the development of life-saving medication. The opportunity to work at the forefront of scientific discovery and technological advancement in the pharma sector was a real motivation. 

A Memorable Start
My Aptio Group story began over coffee in a Danish café where I met Michael Hahn for the first time. His warmth and openness made a lasting impression—and confirmed that Aptio was the place for me. 

Work That Matters
As a mechanical engineer with a focus on HVAC and utility systems, my daily responsibilities include overseeing installation and testing activities in construction. I provide crucial support in developing project documentation, ensuring comprehensive alignment with engineering standards and project goals. 

Always Learning, Always Growing 
The projects are diverse and technically demanding, which keeps me learning and improving. Being part of complex projects allows me to expand my skillset in ways I never imagined. 

Great People, Great Culture 
One of the things I appreciate most is the sense of community. Aptio fosters strong connections through team events, social gatherings, and company trips. Even across borders, we feel like one team.