Driven by many years of experience within the area of Design and Development of Medical Devices and Apps (SaMD) we offer you our expertise within

• Compliance, QMS development and QA
• Design Control, including Systems engineering, Requirements engineering, Architectural Design, Verification and Validation
• Safety Risk Management and Cybersecurity
• Management of Software Development, Advanced Algorithms, and Machine Learning
• Compliance of projects within SaMD, Digital Health and Connectivity
• Audit, internal and supplier, by lead auditors

We work closely together with experts in the areas of Production, Mechanical, Electronics and Chemical Development, Purchasing and Supplier Management, which is not within our primary area of expertise.

Michael Agerkvist knows what is required to develop and approve a complex Medical Device and how to combine quality, safety, and regulatory demands with an effective and efficient development process. Michael is an expert in process improvement, as a QA Manager/Specialist and as a Project Manager. Besides managing, Michael has specific expertise within Safety Risk Management, Cybersecurity, Requirements and Systems Engineering.

WHAT WE DO:

Consultancy

We make up a very strong and experienced team, that we believe can give you invaluable advice when starting up your Medical Device or App (SaMD) Development Project. Some very important decisions regarding your medical claims must be taken early in the project to increase your chance of success.

Our contribution to more experienced and well-established development teams is to fill in with expertise where you need it. You will find that we are very aware of where our competencies are and when we must rely on our network. We have a big network and will find you the best available staffing of the project.

Specifically, our competencies are:

• Process Improvement: Defining and implementing effective Product Development processes in compliance with regulatory requirements
• Project Management: Managing multi-disciplinary projects
• Quality Assurance: Ensuring the right quality while balancing the effort
• Product Development: Scrum and Lean Product Development for medical devices, Requirements Engineering and System Engineering
• MDD, MDR, IVD, IVDR, ISO 13485, ISO 14971, 21 CFR Part 820
• IEC 62304, IEC 82304, IEC 62366, IEC 60601-1, EN 61010, IEC 80002-1, TIR57, TIR97, TIR45
• CMMI, ISO 9000, ISO 9001, FDA, CE
• Internal and supplier audit within: ISO-9001, 13485, 27001, IVDR, MDR, MDSAP

Workshops and training

As part of these services, we also offer workshops and training courses

• Software Development according to 62304, 82304 and TIR45
• Software Risk Management, Requirements Management
• Safety Architectural Patterns, Cybersecurity
• Bring your Medical Device to market, Writing documentation

Advisory board

Through our many years of working with startups and established companies we have become very experienced in assessment of Medical Device Products and Organizations and their ability to obtain approvals according to MDR, IVDR, FDA etc. We offer objective evaluation and advice in relation to the individual Startup company: 

• Capability and maturity of the individual Organization and Medical Device
• Participation in an Advisory Board, which can support the Startup and you with advice on the process of obtaining the required approval
• Plan to go from idea to Medical Device Product in a regulated market
• Organization and development of general and Medical Device specific competences and processes
• Evaluation of technical and regulatory results

 We have a pragmatic and commercial approach to this with focus on maximizing the probability of a successful investment for our client.