We connect the dots –
so you can focus on your business.
We focus our efforts on supporting clients who either lack resources familiar with medical device development or wish to complement their existing resources.Schedule your free consultation Too much on your plate? Get in touch!
Effective project management throughout the entire product lifecycle: keeping projects in time, on budget, and in compliance with ISO 13485 and 21 CFR 820
In vitro Diagnostics
- Structured user centered concept development
- Innovative requirements management - reduced burden of documentation and improved traceability
- Patient preference studies
- Partner network for industrial design, mechanical design, hardware and software design
- Supplier evaluation and audits
- Establishment of EU and US compliant development processes and documentation
- Implementation of risk management processes according to ISO 14971
- Moderation of risk management meetings
- Usability engineering and local support for US or EU handling studies
- Creation of clinical evaluation according to MEDDEV. 2.7.1 by qualified individuals
- Identification and analysis of relevant clinical data
- Clinical Investigations
- Design transfer of development specifications into production and QC specifications
- Project management for upscale projects
- Established partnership for commercial production
- CMO selection and control (audits)
- Audit preparation support
- Remediation projects after audits
Marketing and Sales
- Market research support
- Proven go-to-market strategies
- US-based partnership for market entry strategy, including operations
Service and Customer Feedback
- Professional capture of market feedback for next round of product development
- Compliant processes for post-marketing surveillance
Design Change Projects
- Design History File (DHF)
- Device Master Record (DMR)
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Requirements and Risk Management for Combination Products
Ready for combination products
Comes with a pre-compiled catalog of requirements and risks specific for combination product development.
Intuitive & Fast
Without any training or setup needed, you will be able to quickly ensure full traceability and create reports for your technical file and design history file.
Complete, Adaptable & Scalable
Covers all documentation necessary to fulfil compliance to standards combined with the flexibility to be adapted to your specific needs.