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Services 

This is a Non- complete list, contact us for more information

Hoff

Regulatory 

There are many regulatory requirements that effects companies, Acronyms like IVDR, MDR, FDA, CFR, MD, FCC. EMC, USdot, NRC, WEEE, Rohs and REACH. All represent possible pitfalls to ensure predictable market access.

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Management System

In most regulations for IVD and Medical devices it is a must to have a management system covering the activities needed.

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Trade Compliance

Many companies does not know that they also need to follow many different rules when it comes to trade compliance. These regulations often falls under global agreements to prevent terrorism but also limit access of technology for some countries.

Regulatory Services

Authorised Representative

We are AR within EU! just contact us to get more information about prices and additional services we can provide you with!

PRRC

We are Person Responsible for Regulatory Compliance for many companies in northern Europe. Contact us for mer information what we can help you with!

Start Up Package

We have developed a way of working that help startups or smaller companies to get to the EU market in a easy, compliant and predictable way!

Regulatory strategy

Do you need a global or local strategy for how to get your products to the market!

Classification

Classification of the product defines what rules that applies to your product!

Gap analyse

Do you have the documentation needed för CE marking or 510(k) submission

Management systems

Training

 
  • We can train your organization in areas like product standards, QSR, MDR and  IVDR 


Labelling & Promotion

  • What applies for your products. Avoid warning letter or sales stop building robust system

Authority handling

  • Got a letter from FDA or LV, better contact us to get advice on how to handle this!

General

 
  • Advisory and guidance in projects or permanently, interim handling and internal audits are other common services

Internal Audit

We can help you to perform internal audits, set up the system or give advice on what to do!

QMS Development

Do you need to implement or develop mangament systems in ISO 27001, ISO 14001, ISO 3485 and ISO 9001.

Inspection Support

Have you got a letter from FDA or competent authority about inspection or need help in Notified Body audits! contact us!

Moc Audit

 
  • Do you want to prepare for FDA, Notified body or Competent Authority inspections? or just check compliance status

  • Then we are the right partner!


Quality systems

  • We can help you with all aspects of QSR, ISO 9001, ISO 13485 and ISO 14001. we do parts or complete projects

Regulatory 

  • You might need to ensure that your system meets the regulatory needs for a quality system i.e. adding regulatory specific parts

Strategy

 
  • We can help with all aspects in submission and quality strategies to ensure sustainable market access for your products
  • Dont get behind your competition due to poor planning. Start now!

Trade Compliance

Export Control System

Not having an export control system, to classify products, check customers, and sub suppliers, involved banks etc. Then it is time ta contact us now!

Product Classification

Help in establishing ECCN codes and other important product related classifications. Do you have US content or not?

Export Licenses

We can support in obtaining US (BIS, OFAC), EU or national licenses to export to e.g. embargo or restricted countries. The needs are based on product classification and countries you sell to

Address

Högåsvägen 125
SE- 741 41 Knivsta
Sweden

Contacts

Email: info@lowendahl.eu
Phone: +46 (0) 722 31 33 55

Links

RAQA expert
Clever Compliance

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