We have a team of specialists that can assist on the Master Validation Plan, process verification and validation of manufacturing processes and practices to help your company complies with the local and international quality requirements such as GMP, US QSR and ISO13485.
Allow MedtechBOSS to manage and support you with medical device regulations in ASEAN, Asia and the rest of the world. We emphasize on the importance of having a good regulatory system to help you achieve the best results in the most efficient way. Our "one-stop service" business approach will guide medtech companies through every step of the regulatory process to achieve regulatory compliance.
Our regulatory services includes regulatory strategy planning, preparation of pre-market and post-market documents for submission to authorities, as well as structured procedures with the stakeholders, partners and distributors to meet the regulatory and quality requirements for the product and compliance to the authority.
Our experienced consultants can provide you with their expertise in various fields, namely sales, marketing and logistics
Our extensive network can assist you in locating a suitable distributor in the market that you want to penetrate.
Authentication of document process can be complicated. We connect our clients to authentication services such as notarisation, legalisation, apostille of important documents including Free Sale Certificate and ISO certificates for submission to the authorities.
We have connections to legal, company secretary and accountant to advise on the company set-up. Our team can link you with the appropriate leads to start a new business venture.
Should you need IT solution and government grant awareness information, you can talk directly with the relevant agencies.
Connecting you directly to the Medtech and BioPharma Contractors for manufacturing facilities design and set-up in the Asia region. The contractor will work with the quality, process, risk assessment, system and software validation experts. The expert team consists of individuals that has experiences as the regulator and notified bodies auditor, and joined the biopharma and medtech industry.
Our dedicated support team will assist you whether regulatory or administrative work. We have been helping companies on-site or off-site as their department or temporary support team where they are in needs of help.
The logistics services will manage the flow of your products to optimize productivity, while ensuring compliance to Good Distribution Practice (GDP / GDPMDS). Our dedicated team will assist you with the importation and exportation of your products to the country of destination to the distributors, sub-distributors, hospitals, clinics or consumers.
We provide translation services for important documents to be used in the market required.
Why choose us?
Business One-stop Service (BOSS) for Medtech startup tapping on compliance-ready solution for fast penetration to market
Located at SMF building which creates more business opportunities.
Medical sales expert team with more than 40 years of experience
Your support team in regulatory, IT, finance & admin available