Your Customer Journey with AJW Tech
Expert Support Through Every Stage of Product Development and Compliance
Bringing a regulated product to market is rarely a straight path. From early concept development to post-market responsibilities, each stage presents unique challenges, especially when navigating complex global regulations.
This interactive journey outlines the key stages you may encounter, whether you’re a startup launching your first product or a multinational preparing for expansion. Explore what your team may be working on—like regulatory strategy, risk management, auditing or technical documentation—and discover how AJW Tech provides tailored services and experienced guidance.
Click on the links in each stage to learn how we can help.
1
Ideation & Concept Development
Things You May Be Doing
- Identifying clinical needs
- Conducting brainstorming sessions
- Drafting initial design concepts
2
Regulatory Strategy Development
Things You May Be Doing
- Evaluating market entry requirements for target regions
- Engaging in pre-submission discussions with authorities
- Identifying need for in-country representation
3
Research & Preclinical Testing
Things You May Be Doing
- Conducting initial bench testing and biocompatibility studies
- Selecting materials and components
4
Design & Development
Things You May Be Doing
- Creating prototypes and refining designs
- Developing risk management files
- Conducting verification and validation testing
- Conducting human factors studies
5
Clinical Evaluation & Trials
Things You May Be Doing
- Developing clinical investigation plans
- Literature reviews
- Submitting protocols for ethics committee review
- Conducting pilot studies and clinical trials
6
Regulatory Submission & Market Access
Things You May Be Doing
- Compiling technical documentation
- Securing in-country representation
7
Manufacturing & Quality Assurance
Things You May Be Doing
- Validating manufacturing processes and supply chains
- Establishing cleanroom procedures
- Conducting internal and supplier quality audits
- Finalizing QMS documentation
8
Market Launch
Things You May Be Doing
- Establishing distribution networks and logistics
- Training healthcare providers and sales teams
- Confirming economic operator requirements
9
Post-Market Activities
Things You May Be Doing
- Continuing annual internal and supplier audit programs
- Handling complaints and adverse events
- Investigating and resolving issues
- Conducting PMCF studies