Expert Regulatory Consulting Services

Find out More

Save time & money with the KD&A team

Find out More

Launch products and access new markets

Find out More

01

Medical Device Regulatory Strategy Report

We work with you to develop a plan that helps to get your medical device or IVD to market quickly and efficiently.

KD&A will help you understand what you need to do; when you need to do it, and how much will it cost you. The development of a sound regulatory strategy is an essential starting point for medical device and IVD manufacturers. Designed to provide your organisation with an understanding of specific regulatory requirements in chosen target markets, a Regulatory Strategy Report is your road map to market.

Our Regulatory Strategy Report identifies applicable target market regulatory requirements, and maps out the steps to meet requirements in preparation for market launch. Some requirements will feed into development and testing processes, and therefore must be part of early planning to avoid delays and additional cost.

The KD&A Regulatory Strategy Report includes:

  • Device classification
  • Applicable conformity assessment routes in chosen regions
  • Identification of applicable harmonised standards, guidelines and Common Specifications
  • Expected regulatory fees and time lines
  • Recommended road map to market

We pride ourselves on providing excellent
customer service to our clients

Cyclomedica Australia Pty Ltd

In the 2.5 years we have been working together, no task or challenge is too small or too big. They take both extremes with enthusiasm and ownership not often seen with other consultants. In fact, we don’t see them as consultants, they are an integral part of our team.

James McBrayer,

Managing Director & CEO, Cyclomedica Australia Pty Ltd

CT Healthcare

We have found KD&A’s service, support and understanding invaluable in helping to guide our business through different situations that have arisen. Their work has been done in an extremely professional, efficient and prompt manner, which has been important in situations where immediate action has been needed.

Sean Crealey,

Director of Operations, CT Healthcare

SPD Development Company Ltd

In the 5 years we have been working together, we have found KD&A to be helpful, knowledgeable and always professional. Their ability to provide clear, accurate and timely responses to regulatory enquiries has been valuable to our business.

Graham Howard,

Regulatory Affairs Manager, SPD Development Company

PainChek

We have found KD&A’s services to be solution driven, the team is professional and efficient. I highly recommend KD&A regulatory services and expertise.

Philip Daffas,

CEO, PainChek

Bodyflow International Pty Ltd

“KD&A provided Bodyflow with professional, informative and relevant regulatory advice. In addition, the workshop I attended (held by KD&A along with two other regulatory consultants) allowed for interactive learning – growing my understanding of the requirements for our medical device.”

Dean Libertone,

Compliance Officer, Bodyflow International Pty Ltd

Elastagen Pty Ltd

“KD&A have provided invaluable quality management system and regulatory support as Elastagen has successfully transitioned from an R&D organisation to a clinical stage medical device company operating in compliance with ISO 13485 & 21CFR820. KD&A have been by our side from day 1 and are always available to help with any of our regulatory questions.”

Orsola Regaglia,

Operations Manager, Elastagen Pty Ltd

Opto Global Pty Ltd

“KD&A have been providing Opto global with high quality and professional assistance for 5 years. Their service is delivered efficiently, thoroughly and within the required timeframe.”

Medhat Eldeeb,

Regional Sales Manager, Opto Global Pty Ltd

Signostics Ltd

“We have used KD&A’s services since our inception. Initially, KD&A managed the creation of our quality system, which they implemented quickly and efficiently. Since the initial engagement we have grown and employed quality and regulatory managers, with KD&A continuing to provide quality management and regulatory affairs advice. They have always been responsive and totally professional in their approach and dealings. We have no hesitation in recommending them.”

Stewart Bartlett,

COO, Signostics Ltd

Australian Dental Manufacturing Pty Ltd

“We could not help but come away with respect for, and impressed with, the service KD&A provided to our company. I would not hesitate in recommending KDA to anyone who needs to deal with TGA regulatory requirements.”

Dr. Matthew Athanassiadis,

Director, Australian Dental Manufacturing Pty Ltd

Our team of experts

Kea Dent

Managing Director

Bibiana Franco

Senior Associate

Louise Pirauo

Associate

Mya Imgraben

Assistant

Request a Custom Quote

Complete your information below and our team will be in touch.